Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Inclusion Criteria:

• Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer

  • Recurrent or metastatic disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable indicator lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• Must have received a platinum-containing chemotherapy regimen for primary disease

  • Re-treatment with a platinum-based regimen required for patients who achieved a clinical complete response (CR) to primary therapy and then had a treatment-free interval > 12 months (i.e., platinum-sensitive) unless the patient developed a hypersensitivity to platinum

    • Patients with a treatment-free interval < 12 months do not require prior chemotherapy for recurrent disease
• No evidence of CNS disease, including primary brain tumors or brain metastasis
• Performance status - ECOG 0-2
• More than 3 months
• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• No history of bleeding diathesis
• SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastasis)
• Bilirubin normal
• INR ≤ 1.5 (3 if receiving warfarin)
• No history of esophageal varices
• Creatinine ≤ 1.5 mg/dL
• Creatinine clearance ≥ 60 mL/min
• Urine protein < 1+
• Urine protein < 1,000 mg on 24-hour urine collection
• Urine protein:creatinine ratio < 1.0

• No arterial thromboembolic event within the past 6 months, including any of the following:

  • Transient ischemic attack
  • Cerebrovascular accident
  • Unstable angina pectoris
  • Myocardial infarction
• No clinically significant peripheral artery disease
• No uncontrolled hypertension
• No New York Heart Association grade II-IV congestive heart failure
• No serious cardiac arrhythmia requiring medication
• No peripheral vascular disease ≥ grade 2
• Not pregnant
• No nursing during and for ≥ 3 months after study participation
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 3 months after study participation
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs (e.g., Chinese hamster ovary cell products or recombinant humanized antibodies)
• No serious or non-healing wound, ulcer, or bone fracture
• No active infection requiring parenteral antibiotics
• No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No gastrointestinal tract disease resulting in an inability to take oral medication
• No significant traumatic injury within the past 28 days
• No known HIV positivity
• No prior bevacizumab
• See Disease Characteristics
• No more than 2 prior cytotoxic chemotherapy regimens for recurrent or refractory disease (i.e., failed to achieve a clinical CR after primary therapy)
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• More than 4 weeks since prior radiotherapy
• No prior radiotherapy to any indicator lesion unless disease has progressed since completion of radiotherapy
• More than 4 weeks since prior major surgical procedure or open biopsy
• More than 1 week since prior core biopsy
• No prior surgery affecting absorption
• No concurrent major surgery
• Recovered from prior therapy
• No prior vascular endothelial growth factor (VEGF) or an epidermal growth factor receptor (EGFR) directed therapy
• No prior erlotinib
• At least 30 days since prior investigational drugs
• More than 1 month since prior thrombolytic agents

• Concurrent warfarin allowed provided the following criteria are met:

  • Patient is on a therapeutic stable dose of warfarin
  • INR ≤ 3
  • No active bleeding or pathological condition that would confer a high risk of bleeding (e.g., tumor invading adjacent organs or major blood vessels or varices that are likely to bleed)
• No other concurrent investigational agents
• No other concurrent anticancer therapy