Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
625

Inclusion Criteria

Bilirubin less than or equal to 1.5 x ULN
For patients undergoing NAC-ICS, a core tissue (not fine needle aspiration) biopsy is required; the tissue must be consistent with a Müllerian origin; patients will require documentation of at least stage II or extraovarian sites of disease acquired via imaging or surgery (without attempt at cytoreduction)
Patients with a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma or fallopian tube cancer, stage II -IV suboptimally debulked (any residual disease > 1 cm); International Federation of Gynecology and Obstetrics (FIGO) stage is assessed following the completion of initial abdominal surgery, appropriate imaging studies and with appropriate tissue available for histologic evaluation; the minimum surgery required is an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the GOG Surgical Procedures Manual
...
Bilirubin less than or equal to 1.5 x ULN
For patients undergoing NAC-ICS, a core tissue (not fine needle aspiration) biopsy is required; the tissue must be consistent with a Müllerian origin; patients will require documentation of at least stage II or extraovarian sites of disease acquired via imaging or surgery (without attempt at cytoreduction)
Patients with a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma or fallopian tube cancer, stage II -IV suboptimally debulked (any residual disease > 1 cm); International Federation of Gynecology and Obstetrics (FIGO) stage is assessed following the completion of initial abdominal surgery, appropriate imaging studies and with appropriate tissue available for histologic evaluation; the minimum surgery required is an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the GOG Surgical Procedures Manual
Primary Surgery Patients:
Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl; this ANC cannot have been induced or supported by granulocyte colony stimulating factors
Patients must be entered within 12 weeks of diagnostic/staging surgery
An approved informed consent and authorization permitting release of personal health information and must be signed by the patient or guardian
Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 x ULN
Primary Surgery and Neoadjuvant Chemotherapy with Interval Cytoreductive Surgery Patients:
Patients who have met the pre-entry requirements
Neoadjuvant Chemotherapy (NAC) with Interval Cytoreductive Surgery (ICS) Patients:
After GOG registration, the American College of Radiology [ACR] Imaging Core Laboratory will confirm target lesion as required per protocol; the GOG-eligibility (RECIST) scan and baseline T0 perfusion CT scans will be reviewed prior to the intermediate T1 perfusion CT time point
Creatinine =< 1.5 x institutional upper limit normal (ULN)
Patients must have a GOG performance status of 0, 1, or 2
Patients in this trial may receive ovarian estrogen +/- progestin replacement therapy as indicated at the lowest effective dose(s) for control of menopausal symptoms at any time, but not high-dose progestins for management of anorexia while on protocol-directed therapy or prior to disease progression due to thrombophlebitis risk
All patients enrolled into GOG-0262 at sites where ACRIN 6695 is open will be enrolled in the advanced imaging protocol; patients receiving adjuvant or neoadjuvant chemotherapy are eligible for ACRIN 6695; the following sentence does not apply to those patients entered after 02/08/2012: if a patient declines to participate in the perfusion imaging portion of the protocol, a clinical rationale for declination of imaging form will be completed as part of the data submission for ACRIN 6695
Confirmation of ACRIN 6695 eligibility after the baseline T0 perfusion computed tomography (CT) will be assessed by the ACR Imaging Core Lab: At least one target lesion must have a minimum length of 1 cm in both the long and short axis (as determined by the local site), at least half of the target lesion must have attenuation greater than or equal to 10 Hounsfield Units (HU) on the unenhanced CT, and at least half of the lesion must have maximum enhancement greater than or equal to 5 HU in the perfusion CT scan (as determined by the ACR Imaging Core Lab)
Neuropathy (sensory or motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a partial prothrombin time (PTT) < 1.2 times the upper limit of normal; (heparin, lovenox or alternative anticoagulants are acceptable)
Patients with the following histologic epithelial cell types are eligible: serous, endometrioid, clear cell, mucinous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma; patients may have co-existing fallopian tube carcinoma in-situ so long as the primary origin of invasive tumor is ovarian, peritoneal or fallopian tube; of note, patients with clear cell and mucinous tumors will be eligible unless there is a higher priority protocol
Platelets greater than or equal to 100,000/mcl
Alkaline phosphatase less than or equal to 2.5 x ULN

Exclusion Criteria

Patients with contraindication to iodinated contrast for perfusion CT imaging
Myocardial infarction or unstable angina < 6 months prior to registration
New York Heart Association (NYHA) grade II or greater congestive heart failure
...
Patients with contraindication to iodinated contrast for perfusion CT imaging
Myocardial infarction or unstable angina < 6 months prior to registration
New York Heart Association (NYHA) grade II or greater congestive heart failure
Patients with known allergy to cremophor or polysorbate 80
Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only (such as patients with stage I-A or I-B low grade epithelial ovarian or fallopian tube cancers) are not eligible; patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian, peritoneal primary or fallopian tube cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
Patients with CTCAE grade 2 or greater peripheral vascular disease (at least brief [< 24 hours] episodes of ischemia managed non-surgically and without permanent deficit)
Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
Only applies to patients who elect to receive bevacizumab:
Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator should feel free to consult the Statistical and Data Center (SDC) randomization desk for uncertainty in this regard
Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection; specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24-hour urine collection; obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24-hour urine); send sample to lab with request for urine protein and creatinine levels (separate requests); the lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL); the UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR < 1.0 to allow participation in the study
Patients with metastasis tumor in the parenchyma of the liver or lungs with proximity to large vessels which could make the patients at high risk of lethal hemorrhage during treatment with bevacizumab (ie. hemoptysis, liver rupture)
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab therapy (cycle 2)
Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or fallopian tube cancer; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
Major surgical procedure anticipated during the course of the study; this includes, but is not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression such as colostomy or enterostomy reversal, secondary cytoreductive surgery, or second look surgery; please consult with the SDC Randomization Desk prior to patient entry for any questions related to the classification of surgical procedures
Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer
Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
Patients with acute hepatitis or active infection that requires parenteral antibiotics
Patients who receive Metformin within 48 hours before perfusion CT imaging
With the exception of non-melanoma skin cancer, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy
Patients with a history of CVA within six months
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions
Patients who have received prior therapy with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab
Any tissue biopsy, such as a core biopsy, within 7 days prior to the first date of bevacizumab therapy (cycle 2)
Patients who are pregnant or nursing; patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least six months after completion of bevacizumab therapy
Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition
Serious cardiac arrhythmia requiring medication; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate
Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease

Summary

Conditions
  • Ovarian Mucinous Adenocarcinoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube Mucinous Adenocarcinoma
  • Fallopian Tube Transitional Cell Carcinoma
  • Ovarian Brenner Tumor
  • Ovarian Clear Cell Adenocarcinofibroma
  • Stage IIIB Fallopian Tube Cancer AJCC v7
  • Stage IIIC Ovarian Cancer AJCC v6 and v7
  • Stage IIC Fallopian Tube Cancer AJCC v6 and v7
  • Stage IV Primary Peritoneal Cancer AJCC v7
  • Stage IIIA Primary Peritoneal Cancer AJCC v7
  • Ovarian Endometrioid Adenocarcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Stage IIA Ovarian Cancer AJCC V6 and v7
  • Ovarian Seromucinous Carcinoma
  • Stage IV Ovarian Cancer AJCC v6 and v7
  • Stage IIIA Ovarian Cancer AJCC v6 and v7
  • Stage IIC Ovarian Cancer AJCC v6 and v7
  • Ovarian Serous Adenocarcinoma
  • Stage IIIB Ovarian Cancer AJCC v6 and v7
  • Stage IIIC Primary Peritoneal Cancer AJCC v7
  • Ovarian Transitional Cell Carcinoma
  • Stage IIB Ovarian Cancer AJCC v6 and v7
  • Stage IV Fallopian Tube Cancer AJCC v6 and v7
  • Stage IIIA Fallopian Tube Cancer AJCC v7
  • Stage IIIB Primary Peritoneal Cancer AJCC v7
  • Stage IIA Fallopian Tube Cancer AJCC v6 and v7
  • Ovarian Undifferentiated Carcinoma
  • Stage IIIC Fallopian Tube Cancer AJCC v7
  • Stage IIB Fallopian Tube Cancer AJCC v6 and v7
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only females

Description

PRIMARY OBJECTIVES: I. To determine if the weekly paclitaxel regimen increases the time until first progression or death (progression-free survival [PFS]) compared to the every-3-week paclitaxel regimen in women with primary stage II, III or IV epithelial ovarian, peritoneal or fallopian tube cancer...

PRIMARY OBJECTIVES: I. To determine if the weekly paclitaxel regimen increases the time until first progression or death (progression-free survival [PFS]) compared to the every-3-week paclitaxel regimen in women with primary stage II, III or IV epithelial ovarian, peritoneal or fallopian tube cancer who are receiving carboplatin with or without bevacizumab. SECONDARY OBJECTIVES: I. To determine if the weekly paclitaxel increases the duration of overall survival compared to the every-3-week paclitaxel when combined with carboplatin with or without bevacizumab. II. To compare the weekly paclitaxel to the every-3-week paclitaxel with respect to the incidence of severe or serious adverse events when it is combined with carboplatin with or without bevacizumab. III. To compare the weekly paclitaxel to the every-3-week paclitaxel with respect to patients' self-reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O)-Trial Outcome Index (TOI), when paclitaxel is combined with carboplatin with or without bevacizumab. (As of 02/08/2012, the QOL portion of this study is complete; patients enrolled after this date will not have QOL assessments) TRANSLATIONAL RESEARCH OBJECTIVES: I. To evaluate single nucleotide polymorphisms (SNPs) associated with progression-free survival and toxicity in advanced stage epithelial ovarian, peritoneal and fallopian tube cancer using genome wide association studies (GWAS).* II. To evaluate genomic signatures in tumor tissues which are predictive for patient survival in advanced stage epithelial ovarian, peritoneal and fallopian tube cancer.* III. To evaluate the association between serum and plasma biomarkers and response to anti-angiogenesis therapy in advanced stage epithelial ovarian, peritoneal, and fallopian tube cancer.* NOTE: *As of 02/08/2012, the translational research (TR) portion of this study is complete; patients enrolled after this date will not have TR specimens collected. IMAGING PRIMARY OBJECTIVES: I. To determine whether larger changes in the tumor perfusion parameters from baseline timepoint (T0) to early-therapy T2 are prognostic of higher progression-free survival (PFS) rate at 6 months (PFS-6) from enrollment in patients treated with weekly or every-3-week paclitaxel regimens, who are receiving carboplatin with or without bevacizumab.*** IMAGING SECONDARY OBJECTIVES: I. To determine whether larger changes in tumor perfusion parameters from baseline T0 to intermediate T1 and from T1 to T2 are prognostic of higher PFS-6 in patients treated with weekly or every-3-week paclitaxel regimens, who are receiving carboplatin with or without bevacizumab.*** II. To determine whether larger changes in tumor perfusion parameters values from T0 to T1, T0 to T2, and T1 to T2 are prognostic of better overall survival in all treatment arms.*** III. To assess the association between changes in tumor perfusion parameters before and after chemotherapy initiation (T0 to T1) and subsequent best tumor response according to standard anatomic Response Evaluation Criteria in Solid Tumors (RECIST).*** IV. To assess the association between tumor perfusion parameters before chemotherapy and subsequent best tumor response according to RECIST, PFS-6, and overall survival.*** V. To test the assumption that tumor perfusion parameters are reliable, user-independent, and reproducible parameters of tumor microvascular characteristics; a subgroup of 15 patients will have repeat computed tomography (CT) perfusion studies at the intermediate T1 time point.*** NOTE: ***Patients enrolled after February 8, 2012 must participate in the ACRIN 6695 component at ACRIN-qualified institutions. OUTLINE: Patients are randomized to 1 of 2 treatment arms (beginning on 04-30-2012, the trial is no longer randomized and the chemotherapy regimen is selected and declared prior to enrolling in the study). ARM I (adjuvant chemotherapy suboptimally debulked): Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. ARM II (neoadjuvant chemotherapy with interval cytoreductive surgery): Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Patients in both arms may receive optional** bevacizumab IV over 30-90 minutes on day 1 beginning in course 2. Courses of bevacizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients in Arm II receive bevacizumab during courses 2, 5, and 6 only. NOTE: **Before enrolling onto this study, each patient chooses whether the study treatment will include concurrent and maintenance bevacizumab. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Inclusion Criteria

Bilirubin less than or equal to 1.5 x ULN
For patients undergoing NAC-ICS, a core tissue (not fine needle aspiration) biopsy is required; the tissue must be consistent with a Müllerian origin; patients will require documentation of at least stage II or extraovarian sites of disease acquired via imaging or surgery (without attempt at cytoreduction)
Patients with a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma or fallopian tube cancer, stage II -IV suboptimally debulked (any residual disease > 1 cm); International Federation of Gynecology and Obstetrics (FIGO) stage is assessed following the completion of initial abdominal surgery, appropriate imaging studies and with appropriate tissue available for histologic evaluation; the minimum surgery required is an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the GOG Surgical Procedures Manual
...
Bilirubin less than or equal to 1.5 x ULN
For patients undergoing NAC-ICS, a core tissue (not fine needle aspiration) biopsy is required; the tissue must be consistent with a Müllerian origin; patients will require documentation of at least stage II or extraovarian sites of disease acquired via imaging or surgery (without attempt at cytoreduction)
Patients with a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma or fallopian tube cancer, stage II -IV suboptimally debulked (any residual disease > 1 cm); International Federation of Gynecology and Obstetrics (FIGO) stage is assessed following the completion of initial abdominal surgery, appropriate imaging studies and with appropriate tissue available for histologic evaluation; the minimum surgery required is an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the GOG Surgical Procedures Manual
Primary Surgery Patients:
Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl; this ANC cannot have been induced or supported by granulocyte colony stimulating factors
Patients must be entered within 12 weeks of diagnostic/staging surgery
An approved informed consent and authorization permitting release of personal health information and must be signed by the patient or guardian
Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 x ULN
Primary Surgery and Neoadjuvant Chemotherapy with Interval Cytoreductive Surgery Patients:
Patients who have met the pre-entry requirements
Neoadjuvant Chemotherapy (NAC) with Interval Cytoreductive Surgery (ICS) Patients:
After GOG registration, the American College of Radiology [ACR] Imaging Core Laboratory will confirm target lesion as required per protocol; the GOG-eligibility (RECIST) scan and baseline T0 perfusion CT scans will be reviewed prior to the intermediate T1 perfusion CT time point
Creatinine =< 1.5 x institutional upper limit normal (ULN)
Patients must have a GOG performance status of 0, 1, or 2
Patients in this trial may receive ovarian estrogen +/- progestin replacement therapy as indicated at the lowest effective dose(s) for control of menopausal symptoms at any time, but not high-dose progestins for management of anorexia while on protocol-directed therapy or prior to disease progression due to thrombophlebitis risk
All patients enrolled into GOG-0262 at sites where ACRIN 6695 is open will be enrolled in the advanced imaging protocol; patients receiving adjuvant or neoadjuvant chemotherapy are eligible for ACRIN 6695; the following sentence does not apply to those patients entered after 02/08/2012: if a patient declines to participate in the perfusion imaging portion of the protocol, a clinical rationale for declination of imaging form will be completed as part of the data submission for ACRIN 6695
Confirmation of ACRIN 6695 eligibility after the baseline T0 perfusion computed tomography (CT) will be assessed by the ACR Imaging Core Lab: At least one target lesion must have a minimum length of 1 cm in both the long and short axis (as determined by the local site), at least half of the target lesion must have attenuation greater than or equal to 10 Hounsfield Units (HU) on the unenhanced CT, and at least half of the lesion must have maximum enhancement greater than or equal to 5 HU in the perfusion CT scan (as determined by the ACR Imaging Core Lab)
Neuropathy (sensory or motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a partial prothrombin time (PTT) < 1.2 times the upper limit of normal; (heparin, lovenox or alternative anticoagulants are acceptable)
Patients with the following histologic epithelial cell types are eligible: serous, endometrioid, clear cell, mucinous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma; patients may have co-existing fallopian tube carcinoma in-situ so long as the primary origin of invasive tumor is ovarian, peritoneal or fallopian tube; of note, patients with clear cell and mucinous tumors will be eligible unless there is a higher priority protocol
Platelets greater than or equal to 100,000/mcl
Alkaline phosphatase less than or equal to 2.5 x ULN

Exclusion Criteria

Patients with contraindication to iodinated contrast for perfusion CT imaging
Myocardial infarction or unstable angina < 6 months prior to registration
New York Heart Association (NYHA) grade II or greater congestive heart failure
...
Patients with contraindication to iodinated contrast for perfusion CT imaging
Myocardial infarction or unstable angina < 6 months prior to registration
New York Heart Association (NYHA) grade II or greater congestive heart failure
Patients with known allergy to cremophor or polysorbate 80
Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only (such as patients with stage I-A or I-B low grade epithelial ovarian or fallopian tube cancers) are not eligible; patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian, peritoneal primary or fallopian tube cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
Patients with CTCAE grade 2 or greater peripheral vascular disease (at least brief [< 24 hours] episodes of ischemia managed non-surgically and without permanent deficit)
Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
Only applies to patients who elect to receive bevacizumab:
Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator should feel free to consult the Statistical and Data Center (SDC) randomization desk for uncertainty in this regard
Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection; specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24-hour urine collection; obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24-hour urine); send sample to lab with request for urine protein and creatinine levels (separate requests); the lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL); the UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR < 1.0 to allow participation in the study
Patients with metastasis tumor in the parenchyma of the liver or lungs with proximity to large vessels which could make the patients at high risk of lethal hemorrhage during treatment with bevacizumab (ie. hemoptysis, liver rupture)
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab therapy (cycle 2)
Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or fallopian tube cancer; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
Major surgical procedure anticipated during the course of the study; this includes, but is not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression such as colostomy or enterostomy reversal, secondary cytoreductive surgery, or second look surgery; please consult with the SDC Randomization Desk prior to patient entry for any questions related to the classification of surgical procedures
Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer
Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
Patients with acute hepatitis or active infection that requires parenteral antibiotics
Patients who receive Metformin within 48 hours before perfusion CT imaging
With the exception of non-melanoma skin cancer, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy
Patients with a history of CVA within six months
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions
Patients who have received prior therapy with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab
Any tissue biopsy, such as a core biopsy, within 7 days prior to the first date of bevacizumab therapy (cycle 2)
Patients who are pregnant or nursing; patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least six months after completion of bevacizumab therapy
Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition
Serious cardiac arrhythmia requiring medication; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate
Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease

Locations

Jacksonville, Florida, 32224-9980
Peoria, Illinois, 61614
Sioux City, Iowa, 51102
Charleston, South Carolina, 29425
Norwich, Connecticut, 06360
...
Jacksonville, Florida, 32224-9980
Peoria, Illinois, 61614
Sioux City, Iowa, 51102
Charleston, South Carolina, 29425
Norwich, Connecticut, 06360
Asheville, North Carolina, 28816
Mountain View, California, 94040
Wausau, Wisconsin, 54401
Milwaukee, Wisconsin, 53215
Reno, Nevada, 89502
Pittsburgh, Pennsylvania, 15224
Wailuku, Hawaii, 96793
Easton, Maryland, 21601
Pittsburgh, Pennsylvania, 15232
Anchorage, Alaska, 99508
Savannah, Georgia, 31404
Mobile, Alabama, 36688
Portland, Oregon, 97227
Reno, Nevada, 89502
Kansas City, Missouri, 64118
Mount Holly, New Jersey, 08060
Middletown, New York, 10940
Peoria, Illinois, 61637
Boston, Massachusetts, 02215
Bismarck, North Dakota, 58501
Oshkosh, Wisconsin, 54904
Omaha, Nebraska, 68130
San Jose, California, 95119
South San Francisco, California, 94080
Honolulu, Hawaii, 96813
South Bend, Indiana, 46601
Seoul, 135-720
Flint, Michigan, 48532
Omaha, Nebraska, 68106
Poulsbo, Washington, 98370
Aurora, Colorado, 80045
Des Moines, Iowa, 50309
Peoria, Illinois, 61615
Charlotte, North Carolina, 28203
Helena, Montana, 59601
Rice Lake, Wisconsin, 54868
Salt Lake City, Utah, 84106
Baltimore, Maryland, 21237
Willmar, Minnesota, 56201
West Des Moines, Iowa, 50266
San Rafael, California, 94903
Saint Louis, Missouri, 63110
Princeton, Illinois, 61356
Stevens Point, Wisconsin, 54481
Knoxville, Tennessee, 37920
Weston, Wisconsin, 54476
Newark, Ohio, 43055
Havana, Illinois, 62644
Galveston, Texas, 77555-0565
Bloomington, Illinois, 61704
Maplewood, Minnesota, 55109
Chippewa Falls, Wisconsin, 54729
Green Bay, Wisconsin, 54311
Greenville, Ohio, 45331
Mentor, Ohio, 44060
Rhinelander, Wisconsin, 54501
Havana, Illinois, 62644
Portland, Oregon, 97210
Oakland, California, 94609
Fort Myers, Florida, 33905
Casper, Wyoming, 82609
Spring Valley, Illinois, 61362
Abington, Pennsylvania, 19001
Post Falls, Idaho, 83854
Brightwaters, New York, 11718
South Bend, Indiana, 46601
Wilmington, Ohio, 45177
Columbus, Ohio, 43222
Mason City, Iowa, 50401
Oconto Falls, Wisconsin, 54154
Boise, Idaho, 83706
Winfield, Illinois, 60190
Bronx, New York, 10461
Sacramento, California, 95816
Peru, Illinois, 61354
Clive, Iowa, 50325
Oklahoma City, Oklahoma, 73104
Elkhart, Indiana, 46515
Canton, Ohio, 44710
Honolulu, Hawaii, 96819
Rutherfordton, North Carolina, 28139
Attleboro, Massachusetts, 02703
Jackson, Mississippi, 39216
Robbinsdale, Minnesota, 55422
Drexel Hill, Pennsylvania, 19026
Santa Clara, California, 95051
Walla Walla, Washington, 99362
Spartanburg, South Carolina, 29303
Saint Joseph, Michigan, 49085
Bryn Mawr, Pennsylvania, 19010
Shreveport, Louisiana, 71103
Baltimore, Maryland, 21287
Zanesville, Ohio, 43701
Aurora, Illinois, 60504
Saint Joseph, Michigan, 49085
Lynchburg, Virginia, 24501
Sioux Falls, South Dakota, 57117-5134
Concord, California, 94520
Park Ridge, Illinois, 60068
Los Angeles, California, 90048
Winston-Salem, North Carolina, 27157
Honolulu, Hawaii, 96826
Clive, Iowa, 50325
Kokomo, Indiana, 46904
Westerville, Ohio, 43081
Salt Lake City, Utah, 84143
Mishawaka, Indiana, 46545
New Orleans, Louisiana, 70112
Hot Springs, Arkansas, 71913
Neptune, New Jersey, 07753
Scranton, Pennsylvania, 18510
Seoul, 05505
Sturgeon Bay, Wisconsin, 54235
Lafayette, Colorado, 80026
Philadelphia, Pennsylvania, 19111
Macomb, Illinois, 61455
Springfield, Missouri, 65804
Seattle, Washington, 98112
Dallas, Texas, 75390
Warren, Michigan, 48093
Phoenixville, Pennsylvania, 19460
Saint Louis Park, Minnesota, 55416
Bellefontaine, Ohio, 43311
Oakland, California, 94609
La Porte, Indiana, 46350
Vallejo, California, 94589
Seattle, Washington, 98104
Richmond, Virginia, 23298
Bettendorf, Iowa, 52722
Danbury, Connecticut, 06810
Cleveland, Ohio, 44109
Seattle, Washington, 98195
Pikeville, Kentucky, 41501
Pekin, Illinois, 61554
South San Francisco, California, 94080
Edgewood, Kentucky, 41017
Hartford, Connecticut, 06105
Ames, Iowa, 50010
Decatur, Illinois, 62526
Duluth, Minnesota, 55805
San Leandro, California, 94577
Portland, Oregon, 97239
Madison, Wisconsin, 53792
Fargo, North Dakota, 58122
Urbana, Illinois, 61801
Denver, Colorado, 80205
Dayton, Ohio, 45405
Dallas, Texas, 75235
Lewes, Delaware, 19958
Kalamazoo, Michigan, 49007
Wilmington, North Carolina, 28401
Princeton, Illinois, 61356
Omaha, Nebraska, 68122
Missoula, Montana, 59802
Paoli, Pennsylvania, 19301
Springfield, Massachusetts, 01199
Boiling Springs, South Carolina, 29316
Portland, Maine, 04102
Maplewood, Minnesota, 55109
Southfield, Michigan, 48075
Mishawaka, Indiana, 46545
Seattle, Washington, 98101
Omaha, Nebraska, 68124
Macon, Georgia, 31201
Marietta, Ohio, 45750
Annandale, Virginia, 22003
Kankakee, Illinois, 60901
Murray, Utah, 84107
Akron, Ohio, 44304
Norton, Virginia, 24273
Burnsville, Minnesota, 55337
Stony Brook, New York, 11794
Boston, Massachusetts, 02215
Antigo, Wisconsin, 54409
Duluth, Minnesota, 55805
New York, New York, 10032
Oakland, California, 94611
Kalispell, Montana, 59901
Wynnewood, Pennsylvania, 19096
Richmond, California, 94801
Jamaica, New York, 11432
Danville, Virginia, 24541
Baltimore, Maryland, 21215
Honolulu, Hawaii, 96813
Kansas City, Kansas, 66160
Charlottesville, Virginia, 22908
Worcester, Massachusetts, 01605
Stillwater, Minnesota, 55082
Butte, Montana, 59701
La Jolla, California, 92093
Sacramento, California, 95825
Springfield, Missouri, 65804
Fredericksburg, Virginia, 22408
Seoul, 06273
Camden, New Jersey, 08103
New Orleans, Louisiana, 70112
Akron, Ohio, 44307
Staten Island, New York, 10305
Greenville, South Carolina, 29615
Los Angeles, California, 90095
Shreveport, Louisiana, 71105
Everett, Washington, 98201
Franklin, Ohio, 45005-1066
Prairie Village, Kansas, 66208
Little Rock, Arkansas, 72205
Baltimore, Maryland, 21201
Saint Paul, Minnesota, 55101
Dayton, Ohio, 45415
Elmhurst, Illinois, 60126
Walnut Creek, California, 94596
Gainesville, Georgia, 30501
Baton Rouge, Louisiana, 70817
Columbus, Ohio, 43219
Omaha, Nebraska, 68114
New Hyde Park, New York, 11040
Carthage, Illinois, 62321
Summit, New Jersey, 07902
Royal Oak, Michigan, 48073
Muskegon, Michigan, 49444
Des Moines, Iowa, 50316
Elkhart, Indiana, 46514-2098
Roanoke, Virginia, 24016
Duluth, Minnesota, 55805
Provo, Utah, 84604
Houston, Texas, 77026-1967
Moline, Illinois, 61265
Tucson, Arizona, 85719
Fargo, North Dakota, 58122
Sheridan, Wyoming, 82801
Iron Mountain, Michigan, 49801
Overland Park, Kansas, 66209
Eureka, Illinois, 61530
Columbus, Ohio, 43215
Mount Vernon, Washington, 98274
Baltimore, Maryland, 21204
Ottawa, Illinois, 61350
Rancho Cordova, California, 95670
Emeryville, California, 94608
Philadelphia, Pennsylvania, 19104
Detroit, Michigan, 48202
Green Bay, Wisconsin, 54303
Syracuse, New York, 13210
New Ulm, Minnesota, 56073
Shakopee, Minnesota, 55379
Albany, New York, 12208
Monmouth, Illinois, 61462
Anderson, South Carolina, 29621
Greenbrae, California, 94904
Green Bay, Wisconsin, 54301-3526
Lake Success, New York, 11042
Springfield, Missouri, 65807
Great Falls, Montana, 59405
Norfolk, Virginia, 23502
Omaha, Nebraska, 68131
West Reading, Pennsylvania, 19611
Newark, Delaware, 19718
Oak Lawn, Illinois, 60453-2699
Cleveland, Ohio, 44111
Durham, North Carolina, 27710
Rochester, Minnesota, 55905
Portsmouth, Ohio, 45662
South Bend, Indiana, 46628
Minneapolis, Minnesota, 55407
Normal, Illinois, 61761
Manitowoc, Wisconsin, 54221
Orlando, Florida, 32806
New Orleans, Louisiana, 70112
Lexington, Kentucky, 40536
Lansing, Michigan, 48912
Bethlehem, Pennsylvania, 18015
Waconia, Minnesota, 55387
Rapid City, South Dakota, 57701
Des Moines, Iowa, 50314
Bremerton, Washington, 98310
Wynnewood, Pennsylvania, 19096
Cedar City, Utah, 84720
Pinehurst, North Carolina, 28374
Jackson, Mississippi, 39216
Wailuku, Hawaii, 96793
Chapel Hill, North Carolina, 27599
Stockton, California, 95210
Saint Joseph, Missouri, 64507
Saint Joseph, Missouri, 64506
San Pablo, California, 94806
Tacoma, Washington, 98405
Moline, Illinois, 61265
Mount Vernon, Ohio, 43050
Green Bay, Wisconsin, 54301
Minocqua, Wisconsin, 54548
Liberty, Missouri, 64068
Boston, Massachusetts, 02114
Sequim, Washington, 98384
Billings, Montana, 59101
Columbus, Ohio, 43210
Xenia, Ohio, 45385
Kalamazoo, Michigan, 49048
Monmouth, Illinois, 61462
Providence, Rhode Island, 02905
Silver Spring, Maryland, 20910
Bismarck, North Dakota, 58501
Warrenville, Illinois, 60555
Cleveland, Ohio, 44106
Cleveland, Ohio, 44195
Philadelphia, Pennsylvania, 19107
Oakland, California, 94602
Oakland, California, 94609
Niles, Michigan, 49120
Decatur, Illinois, 62526
Castro Valley, California, 94546
Elkhart, Indiana, 46514
Missoula, Montana, 59802
Fremont, California, 94538
Duluth, Minnesota, 55805
Oakland, California, 94609
Battle Creek, Michigan, 49017
Roseville, California, 95661
Washington, District of Columbia, 20016
Kalispell, Montana, 59901
Las Vegas, Nevada, 89169
Kansas City, Missouri, 64116
South Bend, Indiana, 46617
Burlington, Massachusetts, 01805
Burbank, California, 91505
Fridley, Minnesota, 55432
Joplin, Missouri, 64804
Washington, District of Columbia, 20010
Salt Lake City, Utah, 84112
Sioux Falls, South Dakota, 57105
Philadelphia, Pennsylvania, 19140
Hutchinson, Minnesota, 55350
Toronto, Ontario, M4N 3M5
Wisconsin Rapids, Wisconsin, 54494
Saint Paul, Minnesota, 55102
Edina, Minnesota, 55435
Lancaster, Pennsylvania, 17602
Peoria, Illinois, 61636
Overland Park, Kansas, 66213
Scottsdale, Arizona, 85259
Maywood, Illinois, 60153
Jackson, Michigan, 49201
Bend, Oregon, 97701
Des Moines, Iowa, 50309
Chicago, Illinois, 60612
Springfield, Ohio, 45505
Findlay, Ohio, 45840
Dearborn, Michigan, 48124
Kewanee, Illinois, 61443
Cedar Rapids, Iowa, 52403
Albuquerque, New Mexico, 87106
Santa Rosa, California, 95403
Chillicothe, Ohio, 45601
Lihue, Hawaii, 96766
Plymouth, Indiana, 46563
Brooklyn, New York, 11203
Burlington, Vermont, 05401
Fresno, California, 93720
Hackensack, New Jersey, 07601
New York, New York, 10016
Roseville, California, 95661
Hinsdale, Illinois, 60521
Richmond, Indiana, 47374
Kansas City, Missouri, 64132
San Diego, California, 92123
Morristown, New Jersey, 07960
Big Rapids, Michigan, 49307
Clearwater, Florida, 33756
Hershey, Pennsylvania, 17033-0850
Escanaba, Michigan, 49829
Tucson, Arizona, 85704
Coon Rapids, Minnesota, 55433
Sioux Falls, South Dakota, 57104
Pekin, Illinois, 61554
Lancaster, Ohio, 43130
Port Huron, Michigan, 48060
Tucson, Arizona, 85719
Sioux City, Iowa, 51104
Dayton, Ohio, 45459
Spokane, Washington, 99204
Canton, Illinois, 61520
Walnut Creek, California, 94598
Sioux City, Iowa, 51101
Phoenix, Arizona, 85013
Upland, Pennsylvania, 19013
Kingsport, Tennessee, 37660
Westville, Indiana, 46391
Cedar Rapids, Iowa, 52403
New Britain, Connecticut, 06050
Jacksonville, Florida, 32204
Mukwonago, Wisconsin, 53149
Salt Lake City, Utah, 84103
La Crosse, Wisconsin, 54601
Pontiac, Michigan, 48341
Waukesha, Wisconsin, 53188
Mountain View, California, 94040
Troy, Ohio, 45373
Long Beach, California, 90806
Grand Rapids, Michigan, 49503
Havre, Montana, 59501
Boston, Massachusetts, 02111
Roseville, California, 95678
Castro Valley, California, 94546
Seattle, Washington, 98122-4307
Kansas City, Missouri, 64111
Two Rivers, Wisconsin, 54241
Ann Arbor, Michigan, 48106
Bellingham, Washington, 98226
Milwaukee, Wisconsin, 53233
Carthage, Illinois, 62321
Galesburg, Illinois, 61401
Cincinnati, Ohio, 45219
Oconomowoc, Wisconsin, 53066
Goldsboro, North Carolina, 27534
Livonia, Michigan, 48154
New Orleans, Louisiana, 70121
Iowa City, Iowa, 52242
Honolulu, Hawaii, 96817
Chicago, Illinois, 60631
Ottawa, Illinois, 61350
Chicago, Illinois, 60612
Bismarck, North Dakota, 58501
Honolulu, Hawaii, 96813
San Francisco, California, 94115
Sylmar, California, 91342
Columbus, Ohio, 43228
Voorhees, New Jersey, 08043
San Francisco, California, 94115
Vineland, New Jersey, 08360
Greenville, South Carolina, 29605
Kettering, Ohio, 45429
Normal, Illinois, 61761
Anderson, South Carolina, 29621
Des Moines, Iowa, 50309
Kearney, Nebraska, 68847
Lincoln, Nebraska, 68510
Fort Wayne, Indiana, 46845
Charlotte, North Carolina, 28204
Bangor, Maine, 04401
Billings, Montana, 59102
Birmingham, Alabama, 35233
Sacramento, California, 95823
Canton, Illinois, 61520
Appleton, Wisconsin, 54911
Marshfield, Wisconsin, 54449
Hampton, Virginia, 23666
Chicago, Illinois, 60611
Grand Blanc, Michigan, 48439
Bemidji, Minnesota, 56601
Columbus, Ohio, 43215
Macomb, Illinois, 61455
Moline, Illinois, 61265
Dayton, Ohio, 45409
Detroit, Michigan, 48201
Saint Louis Park, Minnesota, 55416
Des Moines, Iowa, 50314
Palo Alto, California, 94304
Wyoming, Michigan, 49519
Manhasset, New York, 11030
Brainerd, Minnesota, 56401
Bozeman, Montana, 59715
Pittsburgh, Pennsylvania, 15213
Billings, Montana, 59102
Ann Arbor, Michigan, 48106
Louisville, Kentucky, 40202
Mayfield Heights, Ohio, 44124
Seattle, Washington, 98133
Grand Rapids, Michigan, 49503
Summit, Wisconsin, 53066
Munster, Indiana, 46321
American Fork, Utah, 84003
Traverse City, Michigan, 49684
Ridgewood, New Jersey, 07450
Scranton, Pennsylvania, 18508
Omaha, Nebraska, 68198
Chicago, Illinois, 60637
Honolulu, Hawaii, 96817
Eureka, Illinois, 61530
Buffalo, New York, 14263
Michigan City, Indiana, 46360
Fort Collins, Colorado, 80524
Indianapolis, Indiana, 46202
Allentown, Pennsylvania, 18103
Minneapolis, Minnesota, 55415
Vacaville, California, 95688
Sheboygan, Wisconsin, 53081
Eau Claire, Wisconsin, 54701
Sacramento, California, 95817
Indianapolis, Indiana, 46260
Redwood City, California, 94063
West Chester, Pennsylvania, 19380
Lima, Ohio, 45801
Hendersonville, North Carolina, 28791
Fort Lauderdale, Florida, 33316
Tulsa, Oklahoma, 74146
Cincinnati, Ohio, 45220
Englewood, Colorado, 80110
Yakima, Washington, 98902
Las Cruces, New Mexico, 88011
Woodbury, Minnesota, 55125
Hartford, Connecticut, 06102
West Allis, Wisconsin, 53227
Antioch, California, 94531
Louisville, Kentucky, 40202
Great Falls, Montana, 59405
Lexington, Kentucky, 40503
Saint Petersburg, Florida, 33701
Rohnert Park, California, 94928
Phillipsburg, New Jersey, 08865
Houston, Texas, 77030
Saginaw, Michigan, 48601
Marinette, Wisconsin, 54143
Spokane, Washington, 99202
Grand Rapids, Michigan, 49503
Martinez, California, 94553-3156
Normal, Illinois, 61761
Logan, Utah, 84321
Fremont, California, 94538
Fergus Falls, Minnesota, 56537
Stamford, Connecticut, 06904
Orlando, Florida, 32803
Methuen, Massachusetts, 01844
Milwaukee, Wisconsin, 53226
Bridgeport, Connecticut, 06606
Tacoma, Washington, 98405
Ogden, Utah, 84403
Delaware, Ohio, 43015
Green Bay, Wisconsin, 54303
Albuquerque, New Mexico, 87102
Elkton, Maryland, 21921
Oakland, California, 94611
Lakeland, Florida, 33805
Fort Sam Houston, Texas, 78234
Seattle, Washington, 98109
Sacramento, California, 95823
Kalamazoo, Michigan, 49007
New Haven, Connecticut, 06520
Fargo, North Dakota, 58122
Peru, Illinois, 61354
New York, New York, 10065
Temple, Texas, 76508
Flint, Michigan, 48503
Kalispell, Montana, 59901
Beech Grove, Indiana, 46107
Houston, Texas, 77030
Honolulu, Hawaii, 96813
Billings, Montana, 59101
Wenatchee, Washington, 98801
Burlington, North Carolina, 27215
Springfield, Illinois, 62781
Weston, Wisconsin, 54476
Saint George, Utah, 84770
Detroit, Michigan, 48236
West Des Moines, Iowa, 50266-7700
Mineola, New York, 11501
Greenville, South Carolina, 29601
Bloomington, Illinois, 61701
Bremerton, Washington, 98310
Dayton, Ohio, 45406
Seoul, 110-744
Kansas City, Missouri, 64114
Scranton, Pennsylvania, 18501
Saint Louis Park, Minnesota, 55426
Atlanta, Georgia, 30342
Columbus, Ohio, 43214
Seattle, Washington, 98109
Moline, Illinois, 61265
'Aiea, Hawaii, 96701
Los Angeles, California, 90027
Lee's Summit, Missouri, 64086

Tracking Information

NCT #
NCT01167712
Collaborators
NRG Oncology
Investigators
  • Principal Investigator: John K Chan NRG Oncology
  • John K Chan NRG Oncology