A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC 704865, IND 7921) for Recurrent Sex Cord-Stromal Tumors of the Ovary

Inclusion Criteria:

- Histologically confirmed ovarian stromal tumor, including any of the following:

- Granulosa cell tumor

- Granulosa cell-theca cell tumor

- Sertoli-Leydig cell tumor (androblastoma)

- Steroid (lipid) cell tumor

- Gynandroblastoma

- Unclassified sex cord-stromal tumor

- Sex cord tumor with annular tubules

- Recurrent disease

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan

- No tumor involving major vessels

- No history or evidence of primary brain tumor or brain metastases by physical exam

- GOG performance status 0-2

- ANC ≥ 1,000/µL

- Platelet count ≥ 75,000/µL

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT < 2.5 times ULN

- Alkaline phosphatase < 2.5 times ULN

- INR ≤ 1.5 (in-range INR [2-3] if patient is on a stable dose of therapeutic warfarin)

- PTT < 1.2 times ULN

- Creatinine ≤ 1.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 3 months after
completion of study treatment

- Serious non-healing wound, ulcer, or bone fracture

- Active bleeding or pathologic conditions that carry a high risk of bleeding,
including any of the following:

- Known bleeding disorder

- Coagulopathy

- History or evidence of other CNS disease by physical exam, including any of the
following:

- Seizures not controlled with standard medical therapy

- Cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage
within the past 6 months

- Sensory and motor neuropathy > grade 1 (according to NCI CTCAE v3.0)

- Clinically significant cardiovascular disease, including any of the following:

- Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg
or diastolic BP > 90 mm Hg

- Myocardial infarction or unstable angina within the past 6 months

- New York Heart Association class II-IV congestive heart failure

- Serious cardiac arrhythmic requiring medication

- Peripheral vascular disease ≥ grade 2

- Clinically significant peripheral artery disease (e.g., claudication within the past
6 months)

- Clinically significant proteinuria (urine protein:creatinine ratio ≥ 1.0)

- Known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human or humanized antibodies

- Bowel obstruction or requirement for parenteral hydration and/or nutrition

- Significant traumatic injury within the past 28 days

- Active infection requiring parenteral antibiotics

- Other invasive malignancies within the past 5 years, except non-melanoma skin cancer

- No prior treatment with bevacizumab or other VEGF inhibitors

- No prior cancer treatment that contraindicates study therapy

- No major surgical procedure or open biopsy within the past 28 days

- No vascular access device placement or core biopsy within the past 7 days

- No concurrent major surgery

- No other concurrent chemotherapy, radiotherapy, immunotherapy, or hormonal therapy
directed against the tumor