Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Inclusion Criteria:

• Diagnosis of ovarian epithelial, primary peritoneal, or fallopian tube cancer
• Recurrent disease
• Must have received a prior platinum-based regimen
• Platinum-sensitive (treatment-free interval > 6 months)
• No more than 2 prior chemotherapy regimens
• Measurable disease
• At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
• Not in a prior irradiation field
• No known brain metastases

• Performance status:

  • ECOG 0-2 OR
  • Karnofsky 80-100%

• Life expectancy:

  • More than 12 weeks

• Hematopoietic:

  • Absolute neutrophil count >= 1,500/mm3
  • Platelet count >= 100,000/mm3
  • Hemoglobin >= 9 g/dL
  • No bleeding diathesis

• Hepatic:

  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST or ALT =< 2 times ULN
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other agents used in the study
• Patients who have had a reaction to a taxane or a platinum and have not yet been rechallenged may undergo a desensitization regimen on study
• No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor El:
• Prior hypersensitivity reaction to paclitaxel allowed provided rechallenged successfully

• Renal:

  • Creatinine < 2 mg/dL

• Cardiovascular:

  • Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed if stable for the past 6 months
  • No symptomatic congestive heart failure
  • No uncontrolled hypertension
  • No cardiac arrhythmia
  • No unstable angina pectoris;
  • No myocardial infarction within the past 6 months
• Negative pregnancy test
• Fertile patients must use effective contraception
• Adequate intestinal function
• No concurrent requirements for IV hydration or nutritional support
• No active or ongoing infection
• No psychiatric illness or social situation that would preclude study compliance
• No other concurrent uncontrolled illness
• No other invasive malignancy with the past 5 years except nonmelanoma skin cancer
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• More than 3 weeks since prior hormonal therapy
• More than 4 weeks since prior radiotherapy and recovered
• No prior sorafenib
• No prior anticancer therapy that contraindicates study therapy
• No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort)
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent therapeutic anticoagulation therapy
• Concurrent prophylactic low-dose warfarin allowed for maintenance of venous or arterial access devices
• No other concurrent anticancer therapies
• No other concurrent investigational agents
• Not pregnant or nursing