Bevacizumab in Treating Patients With 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