Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
50

Inclusion Criteria

At least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging
Total bilirubin within normal institutional limits
No active infection requiring antibiotics
...
At least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging
Total bilirubin within normal institutional limits
No active infection requiring antibiotics
Stable from a cardiopulmonary standpoint to continue with prolonged surgery and anesthesia
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 or low molecular weight heparin) and a partial thromboplastin time (PTT) < 1.2 times control
Absolute neutrophil count (ANC) >= 1,500/mcL
Serum albumin >= 2.5
Neoadjuvant chemotherapy must be held for at least 3 weeks prior to surgery
Candidate for potentially radical, maximal effort cytoreductive surgery at the discretion and expertise of the treating physician
Platelets (PLT) >= 100,000/mcL
Patients who are platinum-sensitive or platinum resistant
Gynecologic Oncology Group (GOG) or Eastern Cooperative Oncology Group (ECOG) performance status =< 1 or Karnofsky scale (KPS) >= 70%
Neuropathy (sensory and motor) NCI CTCAE grade =< 2
Preoperative or intraoperative (frozen section) diagnosis of ovarian, peritoneal, fallopian tubal or uterine cancer
Patient with primary or recurrent International Federation of Gynecology and Obstetrics (FIGO) stage III or IV, or recurrent ovarian, fallopian tube, peritoneal carcinoma, or uterine cancer, confined to abdominal cavity, including those who have completed neoadjuvant chemotherapy and primary surgery
White blood cell (WBC) >= 3,000/mcL
Resolution of any effects of prior therapy (except alopecia and peripheral neuropathy) to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) grade =< 1 and to baseline laboratory values as defined
Provided informed consent
Hemoglobin (HGB) >= 9 g/dL
Creatinine < 1.5 x ULN or creatinine clearance > 60 ml/min according to Cockcroft-Gault formula
Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) < 2.5 x institutional upper limit of normal (ULN)
Decline in serum cancer antigen (CA) 125 level
Surgery achieves either no gross residual disease (R0) or optimal cytoreductive status defined as no single lesion measuring more than 5.0 mm in its greatest diameter
Improvement of ascites volume

Exclusion Criteria

Patients with active extra-abdominal disease including active malignant pleural effusion; patients who have been successfully treated with neoadjuvant chemotherapy and no longer have (malignant) pleural effusions may be included
Sub-optimal resection as their surgical outcome
Metastatic non-gynecologic or breast primaries
...
Patients with active extra-abdominal disease including active malignant pleural effusion; patients who have been successfully treated with neoadjuvant chemotherapy and no longer have (malignant) pleural effusions may be included
Sub-optimal resection as their surgical outcome
Metastatic non-gynecologic or breast primaries
Doubling of serum CA-125 level
Other active invasive malignancies, with the exception of non-melanoma skin cancer and breast cancer (if without evidence of disease 1 year after completion of treatment)
Intraoperative frozen section suggesting hepatobiliary, pancreatic, adrenal, or urinary tract cancer
Patients whose circumstances do not permit completion of the study or the required follow-up
Clinical deterioration (worsening ascites, carcinomatous ileus, malignant bowel obstruction, severe hypoalbuminemia, declining performance status)
Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery
Pregnant, nursing, or of childbearing potential and refuse hysterectomy or bilateral salpingo-oophorectomy
At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions

Summary

Conditions
  • Stage III Ovarian Cancer AJCC v6 and v7
  • FIGO Stage IVA Ovarian Cancer
  • FIGO Stage IVB Ovarian Cancer
  • Stage IIIC Fallopian Tube Cancer AJCC v7
  • Stage IIIC Ovarian Cancer AJCC v6 and v7
  • Platinum-Resistant Ovarian Carcinoma
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Stage IV Uterine Corpus Cancer AJCC v7
  • Stage IVA Uterine Corpus Cancer AJCC v7
  • Stage IIIB Fallopian Tube Cancer AJCC v7
  • Stage IIIC Primary Peritoneal Cancer AJCC v7
  • Stage IV Fallopian Tube Cancer AJCC v6 and v7
  • Recurrent Uterine Corpus Carcinoma
  • Stage IVB Uterine Corpus Cancer AJCC v7
  • Stage IIIA Ovarian Cancer AJCC v6 and v7
  • Stage IIIB Primary Peritoneal Cancer AJCC v7
  • Stage III Fallopian Tube Cancer AJCC v7
  • Stage IIIB Ovarian Cancer AJCC v6 and v7
  • Stage IV Ovarian Cancer AJCC v6 and v7
  • Stage IIIA Fallopian Tube Cancer AJCC v7
  • Stage IV Primary Peritoneal Cancer AJCC v7
  • Stage IIIA Primary Peritoneal Cancer AJCC v7
  • Stage III Primary Peritoneal Cancer AJCC v7
  • Stage IIIB Uterine Corpus Cancer AJCC v7
  • Stage III Uterine Corpus Cancer AJCC v7
  • Stage IIIA Uterine Corpus Cancer AJCC v7
  • Stage IIIC Uterine Corpus Cancer AJCC v7
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only females

Description

PRIMARY OBJECTIVE: I. To determine whether cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) followed by postoperative normothermic intraperitoneal (IP) chemotherapy is feasible and safe to administer, as measured by toxicities occurring during treatment or follow-up. SECO...

PRIMARY OBJECTIVE: I. To determine whether cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) followed by postoperative normothermic intraperitoneal (IP) chemotherapy is feasible and safe to administer, as measured by toxicities occurring during treatment or follow-up. SECONDARY OBJECTIVES: I. To determine quality of life (QoL) and compare the outcomes to a historical control of IP chemotherapy (no HIPEC) for women with ovarian cancer. II. To determine whether cytoreductive surgery with HIPEC alone is feasible and safe to administer, as measured by toxicities occurring during treatment or follow-up. III. To estimate progression-free survival (PFS). IV. To collect biospecimens and perform correlative translational studies focused on understanding the mechanisms of action of HIPEC on ovarian cancer. OUTLINE: Patients undergo surgery and receive hyperthermic cisplatin intraperitoneally (IP) over 60 minutes. Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or intravenously (IV) at the discretion of the medical and gynecologic oncologists. After completion of study treatment, patients are followed up at 3-6, 6-9, 9-12, and 12-15 months; every 3 months for 1 year; and then every 4 months for 1 year.

Inclusion Criteria

At least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging
Total bilirubin within normal institutional limits
No active infection requiring antibiotics
...
At least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging
Total bilirubin within normal institutional limits
No active infection requiring antibiotics
Stable from a cardiopulmonary standpoint to continue with prolonged surgery and anesthesia
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 or low molecular weight heparin) and a partial thromboplastin time (PTT) < 1.2 times control
Absolute neutrophil count (ANC) >= 1,500/mcL
Serum albumin >= 2.5
Neoadjuvant chemotherapy must be held for at least 3 weeks prior to surgery
Candidate for potentially radical, maximal effort cytoreductive surgery at the discretion and expertise of the treating physician
Platelets (PLT) >= 100,000/mcL
Patients who are platinum-sensitive or platinum resistant
Gynecologic Oncology Group (GOG) or Eastern Cooperative Oncology Group (ECOG) performance status =< 1 or Karnofsky scale (KPS) >= 70%
Neuropathy (sensory and motor) NCI CTCAE grade =< 2
Preoperative or intraoperative (frozen section) diagnosis of ovarian, peritoneal, fallopian tubal or uterine cancer
Patient with primary or recurrent International Federation of Gynecology and Obstetrics (FIGO) stage III or IV, or recurrent ovarian, fallopian tube, peritoneal carcinoma, or uterine cancer, confined to abdominal cavity, including those who have completed neoadjuvant chemotherapy and primary surgery
White blood cell (WBC) >= 3,000/mcL
Resolution of any effects of prior therapy (except alopecia and peripheral neuropathy) to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) grade =< 1 and to baseline laboratory values as defined
Provided informed consent
Hemoglobin (HGB) >= 9 g/dL
Creatinine < 1.5 x ULN or creatinine clearance > 60 ml/min according to Cockcroft-Gault formula
Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) < 2.5 x institutional upper limit of normal (ULN)
Decline in serum cancer antigen (CA) 125 level
Surgery achieves either no gross residual disease (R0) or optimal cytoreductive status defined as no single lesion measuring more than 5.0 mm in its greatest diameter
Improvement of ascites volume

Exclusion Criteria

Patients with active extra-abdominal disease including active malignant pleural effusion; patients who have been successfully treated with neoadjuvant chemotherapy and no longer have (malignant) pleural effusions may be included
Sub-optimal resection as their surgical outcome
Metastatic non-gynecologic or breast primaries
...
Patients with active extra-abdominal disease including active malignant pleural effusion; patients who have been successfully treated with neoadjuvant chemotherapy and no longer have (malignant) pleural effusions may be included
Sub-optimal resection as their surgical outcome
Metastatic non-gynecologic or breast primaries
Doubling of serum CA-125 level
Other active invasive malignancies, with the exception of non-melanoma skin cancer and breast cancer (if without evidence of disease 1 year after completion of treatment)
Intraoperative frozen section suggesting hepatobiliary, pancreatic, adrenal, or urinary tract cancer
Patients whose circumstances do not permit completion of the study or the required follow-up
Clinical deterioration (worsening ascites, carcinomatous ileus, malignant bowel obstruction, severe hypoalbuminemia, declining performance status)
Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery
Pregnant, nursing, or of childbearing potential and refuse hysterectomy or bilateral salpingo-oophorectomy
At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions

Tracking Information

NCT #
NCT01970722
Collaborators
National Cancer Institute (NCI)
Investigators
  • Principal Investigator: Thanh Dellinger City of Hope Medical Center
  • Thanh Dellinger City of Hope Medical Center
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