Bevacizumab and Low-Dose Cyclophosphamide in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma, Stage IV Ovarian Cancer
About this trial
This is an interventional treatment trial for Primary Peritoneal Carcinoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed recurrent or metastatic ovarian epithelial or primary peritoneal cancer Unidimensionally measurable disease Previously irradiated indicator lesions must have progressed after radiotherapy Received a platinum-containing regimen for primary disease No more than 2 prior chemotherapy regimens for recurrent disease Must have received prior platinum-based chemotherapy for recurrent disease if it has been > 12 months since treatment for primary disease (except if hypersensitivity to platinum has developed) Rechallenge with the same platinum-based regimen is considered 1 prior regimen No history or clinical evidence of CNS disease, including primary brain tumor No brain metastases Performance status - SWOG 0-2 At least 3 months Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No bleeding diathesis No coagulopathy Bilirubin no greater than 1.5 times normal ALT or AST no greater than 3 times upper limit of normal INR less than 1.5 (for patients receiving warfarin) Creatinine no greater than 1.5 times normal No proteinuria (less than 1+) Proteinuria less than 500 mg/24-hour urine collection No prior deep vein thrombosis No prior stroke No clinically significant cardiovascular disease None of the following within the past year: Uncontrolled hypertension New York Heart Association class II-IV congestive heart failure Serious cardiac arrhythmia requiring medication Grade II or greater peripheral vascular disease None of the following within the past 6 months: Unstable angina Myocardial infarction Transient ischemic attack Cerebrovascular accident Other arterial thromboembolic event No clinically significant peripheral artery disease No active infection requiring parenteral antibiotics No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies Not pregnant or nursing Fertile patients must use effective contraception No serious, non-healing wound, ulcer, or bone fracture No significant traumatic injury within the past 28 days No seizures not controlled with standard medical therapy No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix All prior invasive malignancies must be in complete remission No other concurrent medical, psychological, or social condition that would preclude study participation No prior antiangiogenesis agents See Disease Characteristics Recovered from prior chemotherapy See Disease Characteristics Recovered from prior radiotherapy More than 28 days since prior major surgical procedure or open biopsy and recovered At least 3 weeks since prior therapy directed at the malignancy No recent or concurrent full-dose anticoagulants or thrombolytic agents Anticoagulants to maintain patency of preexisting, permanent indwelling IV catheters allowed No concurrent chronic daily aspirin (greater than 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function
Sites / Locations
- City of Hope Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (bevacizumab, cyclophosphamide)
Patients receive bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.