Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer
About this trial
This is an interventional treatment trial for Primary Peritoneal Cavity Cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed ovarian epithelial or primary peritoneal carcinoma Recurrent or persistent after initial standard surgery or chemotherapy Incurable with standard surgery, chemotherapy, or radiotherapy At least 1 unidimensionally measurable target lesion At least 20 mm by conventional techniques At least 10 mm by spiral CT scan Outside the area of prior radiotherapy Accessible to guided core needle biopsy Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or another organoplatinum compound) for primary disease May have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment Patients with only 1 prior platinum-based chemotherapy regimen must have an initial treatment-free interval of less than 12 months Patients with an initial treatment-free interval of more than 12 months must have progressive disease after prior platinum-based chemotherapy regimen as second-line therapy No tumors involving major blood vessels No evidence of CNS disease (primary brain tumor or brain metastases) within the past 5 years Ineligible for higher priority Gynecologic Oncology Group (GOG) protocols (i.e., active phase III GOG protocols for the same patient population) Performance status - GOG 0-2 (patients who have received 1 prior regimen) Performance status - GOG 0-1 (patients who have received 2 prior regimens) Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No known bleeding disorder or coagulopathy No active bleeding Bilirubin ≤ 1.5 times upper limit of normal (ULN) serum glutamate oxaloacetate transaminase (SGOT) ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN PT (INR) ≤ 1.5 (INR 2-3 if on stable dose of therapeutic warfarin or low molecular weight heparin) Partial thromboplastin time (PTT) < 1.2 times control Creatinine ≤ 1.5 times ULN Creatinine clearance > 60 mL/min No proteinuria, as indicated by 1 of the following: Negative urine dipstick Urine protein < 30 mg/dL Urine protein < 1,000 mg on 24-hour urine collection No clinically significant cardiovascular disease, including any of the following: Uncontrolled hypertension Myocardial infarction within the past 6 months Unstable angina within the past 6 months New York Heart Association class II-IV congestive heart failure Serious cardiac arrhythmia requiring medication Peripheral vascular disease ≥ grade 2 No stroke within the past 5 years No pathologic condition that carries a high risk of bleeding No significant traumatic injury within the past 28 days No other invasive malignancy within the past 5 years except nonmelanoma skin cancer No uncontrolled seizures within the past 5 years No neuropathy (motor and sensory) ≥ grade 2 No serious non-healing wound, ulcer, or bone fracture No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies No active infection requiring parenteral antibiotics No known claustrophobia that would preclude MRI tolerance No ferromagnetic implants or pacers Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study treatment At least 3 weeks since prior immunologic therapy directed at malignancy No prior bevacizumab No other concurrent immunotherapy directed at malignancy One additional prior cytotoxic regimen for recurrent or persistent disease allowed No prior non-cytotoxic chemotherapy for recurrent or persistent disease No concurrent chemotherapy directed at malignancy At least 1 week since prior hormonal therapy directed at malignancy No concurrent hormonal therapy directed at malignancy Concurrent hormone replacement therapy allowed Recovered from prior radiotherapy No concurrent radiotherapy directed at malignancy At least 28 days since prior major surgery or open biopsy and recovered At least 7 days since prior core biopsy or placement of vascular access device No anticipated need for major surgical procedure during study participation At least 3 weeks since other prior therapy directed at malignancy No prior anticancer therapy that would preclude study entry
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (bevacizumab)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.