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

PRIMARY OBJECTIVES :

I. Compare the progression-free and overall survival rate of patients with recurrent platinum-sensitive ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with sorafenib with or without carboplatin and paclitaxel. (Arm I [sorafenib only] closed to accrual 10/01/2008) II. Evaluate the response rate and time to disease progression in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to performance status and participating center.

ARM I (closed to accrual 10/01/2008): Patients receive oral sorafenib twice daily on days 1-28.Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II.

ARM II: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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