Phase II Clinical Trial Of Bevacizumab (IND 7,921; NSC 704865) And Low Dose Oral Cyclophosphamide In Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma

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