Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Condition: Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
MeSH terms: Carcinoma; Fallopian Tube Neoplasms; Recurrence
Intervention: Carboplatin; Paclitaxel; Sorafenib Tosylate
Intervention description: Given IV; Given IV; Given orally
Intervention MeSH terms: Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel; Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their
      growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as
      paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they
      stop growing or die. Giving sorafenib together with chemotherapy may kill more tumor cells.
      This randomized phase II trial is studying how well giving sorafenib together with paclitaxel
      and carboplatin works in treating patients with recurrent ovarian cancer, primary peritoneal
      cancer, or fallopian tube cancer. (Sorafenib only group closed as of 10/10/2008).
    

Eligibility criteria:

        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