Recruitment

Recruitment Status
Terminated
Estimated Enrollment
66

Inclusion Criteria

Life expectancy >12 weeks
Women over 18 years old
Planned interval debulking surgery
...
Life expectancy >12 weeks
Women over 18 years old
Planned interval debulking surgery
Obtained informed consent, in writing and signed
Histological confirmation of primary peritoneal carcinoma or fallopian tube carcinoma
ECOG:0 to 2

Exclusion Criteria

Pre-existing sensory or motor neuropathy, ≥ grade 2
Prior exposure to mouse CA-125 antibody.
Peripheral vascular disease ≥ grade 3 (i.e. symptomatic and interfering with activities or daily living [ADL] needing repair or review)
...
Pre-existing sensory or motor neuropathy, ≥ grade 2
Prior exposure to mouse CA-125 antibody.
Peripheral vascular disease ≥ grade 3 (i.e. symptomatic and interfering with activities or daily living [ADL] needing repair or review)
Demonstration of any other neurological or metabolic dysfunction involving a reasonable suspicion of the existence of a disease or condition that contraindicates the use of an experimental drug, or that involves an increased risk to the patient of treatment-related complications
Women that are breastfeeding or pregnant.
Non-healing wound, active peptic ulcer or bone fracture. Patients with healing incised granulomas by secondary intention, with no evidence of fascial dehiscence or infection can be included, but they require three weeks of wound control.
Current or recent use (within 10 days before the first cycle of treatment) of full doses of anticoagulants or thrombolytics administered orally or parenterally for therapeutic purposes (except for vascular permeability, in which case the INR should be kept below 1.5).
Poorly controlled cardiac arrhythmia despite medication (may include patients with atrial fibrillation with controlled frequency)
Non-epithelial ovarian cancer, including malignant mixed Müllerian tumors.
No medical or psychiatric illness that may impede the performance of a systemic or surgical treatment
Known hypersensitivity to bevacizumab or any of its excipients (including Cremophor).
Cerebrovascular accident (CVA), transient ischemic attack (TIA) or subarachnoid haemorrhage (SAH) in the 6 months prior to randomization.
Treatment with any other experimental product, or participation in another clinical trial within 30 days prior to inclusion.
Malignant tumors other than ovarian cancer within the 5 years prior to randomisation, with the exception of cervical carcinoma in situ treated correctly and/or basal-cell carcinoma.
History or clinical suspicion of brain metastases or spinal cord compression.
Previous systemic anti-tumor treatment against ovarian cancer.
Congestive heart failure (CHF) class ≥ II of the NYHA (New York Heart Association)
Major traumatic injuries in the 4 weeks prior to the first potential dose of bevacizumab.
Laboratory:
Intestinal obstruction or sub-occlusion, intestinal infiltration shown by CT scan or rectosigmoid infiltration in gynaecological examination.
Fertile women of childbearing age who are not willing to use effective contraception during the study and at least 6 months after the study.
History or evidence of central nervous system (CNS) disorders, unless properly treated with standard medical treatment.
Administration of intraperitoneal chemotherapy planned.
Myocardial infarction or unstable angina (≤ 6 months before randomization)
Any previous radiotherapy: abdomen or pelvis.
Current or recent continued use of aspirin > 325 mg / day (within 10 days prior to randomization)
Borderline ovarian tumors.
Uncontrolled hypertension.
History or evidence of bleeding or thrombotic diathesis

Summary

Conditions
Cancer - Ovarian
Type
Interventional
Phase
Phase 2
Design
  • Allocation: 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

Epithelial ovarian cancer (OC) is the fourth leading cause of cancer death in women, after lung, breast and colon cancer, and it represents the most common cause of death from gynaecological malignancies. The high mortality associated with OC is due to the lack of screening tests that enable an earl...

Epithelial ovarian cancer (OC) is the fourth leading cause of cancer death in women, after lung, breast and colon cancer, and it represents the most common cause of death from gynaecological malignancies. The high mortality associated with OC is due to the lack of screening tests that enable an early diagnosis, thus the majority of patients are diagnosed at advanced stages of the disease when the chances of a cure are very limited. In fact, the 5-year overall survival (OS) rate for stage III-IV OC does not exceed 20-30% in many series. The standard treatment for advanced OC is maximal cytoreductive surgery (or debulking) followed by the administration of 6 cycles of adjuvant chemotherapy with carboplatin and paclitaxel. In recent years, a number of studies have been carried out with antiangiogenic drugs. Specifically, bevacizumab, an anti-VEGF monoclonal antibody, has been shown to be active both in monotherapy and combination therapy in patients with OC that have received multiple previous lines of chemotherapy. One of the objectives is to evaluate whether the addition of neoadjuvant bevacizumab improves the response and whether this affects the evolution of patients.

Inclusion Criteria

Life expectancy >12 weeks
Women over 18 years old
Planned interval debulking surgery
...
Life expectancy >12 weeks
Women over 18 years old
Planned interval debulking surgery
Obtained informed consent, in writing and signed
Histological confirmation of primary peritoneal carcinoma or fallopian tube carcinoma
ECOG:0 to 2

Exclusion Criteria

Pre-existing sensory or motor neuropathy, ≥ grade 2
Prior exposure to mouse CA-125 antibody.
Peripheral vascular disease ≥ grade 3 (i.e. symptomatic and interfering with activities or daily living [ADL] needing repair or review)
...
Pre-existing sensory or motor neuropathy, ≥ grade 2
Prior exposure to mouse CA-125 antibody.
Peripheral vascular disease ≥ grade 3 (i.e. symptomatic and interfering with activities or daily living [ADL] needing repair or review)
Demonstration of any other neurological or metabolic dysfunction involving a reasonable suspicion of the existence of a disease or condition that contraindicates the use of an experimental drug, or that involves an increased risk to the patient of treatment-related complications
Women that are breastfeeding or pregnant.
Non-healing wound, active peptic ulcer or bone fracture. Patients with healing incised granulomas by secondary intention, with no evidence of fascial dehiscence or infection can be included, but they require three weeks of wound control.
Current or recent use (within 10 days before the first cycle of treatment) of full doses of anticoagulants or thrombolytics administered orally or parenterally for therapeutic purposes (except for vascular permeability, in which case the INR should be kept below 1.5).
Poorly controlled cardiac arrhythmia despite medication (may include patients with atrial fibrillation with controlled frequency)
Non-epithelial ovarian cancer, including malignant mixed Müllerian tumors.
No medical or psychiatric illness that may impede the performance of a systemic or surgical treatment
Known hypersensitivity to bevacizumab or any of its excipients (including Cremophor).
Cerebrovascular accident (CVA), transient ischemic attack (TIA) or subarachnoid haemorrhage (SAH) in the 6 months prior to randomization.
Treatment with any other experimental product, or participation in another clinical trial within 30 days prior to inclusion.
Malignant tumors other than ovarian cancer within the 5 years prior to randomisation, with the exception of cervical carcinoma in situ treated correctly and/or basal-cell carcinoma.
History or clinical suspicion of brain metastases or spinal cord compression.
Previous systemic anti-tumor treatment against ovarian cancer.
Congestive heart failure (CHF) class ≥ II of the NYHA (New York Heart Association)
Major traumatic injuries in the 4 weeks prior to the first potential dose of bevacizumab.
Laboratory:
Intestinal obstruction or sub-occlusion, intestinal infiltration shown by CT scan or rectosigmoid infiltration in gynaecological examination.
Fertile women of childbearing age who are not willing to use effective contraception during the study and at least 6 months after the study.
History or evidence of central nervous system (CNS) disorders, unless properly treated with standard medical treatment.
Administration of intraperitoneal chemotherapy planned.
Myocardial infarction or unstable angina (≤ 6 months before randomization)
Any previous radiotherapy: abdomen or pelvis.
Current or recent continued use of aspirin > 325 mg / day (within 10 days prior to randomization)
Borderline ovarian tumors.
Uncontrolled hypertension.
History or evidence of bleeding or thrombotic diathesis

Locations

Madrid
Barcelona
Murcia
Hospitalet del Llobregat
Badalona
...
Madrid
Barcelona
Murcia
Hospitalet del Llobregat
Badalona
Valencia, Comunidad Valenciana, 46026
Palma Mallorca
Cordoba
Santander
Barcelona
Madrid
Girona
Sabadell

Tracking Information

NCT #
NCT01847677
Collaborators
Roche Pharma AG
Investigators
Study Chair: Yolanda García, MD C.S Parc Taulí