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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Moffitt Cancer Center at Tampa General Hospital
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Case Western Reserve University
Cleveland, Ohio, United States
Lake University Ireland Cancer Center
Mentor, Ohio, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.
Time frame: after 6 weeks (2 cycles)
Evaluate the Progression-free Survival Rate
Progression free survival (PFS) was measured by months from the date of treatment to the date of death or the date of progression, and censored at the date of last follow-up for those alive without progression.
Time frame: up to 85 months of follow-up
Overall Survival
Overall survival time, in months, is calculated from the date of treatment to date of death, and to date of last follow-up for those still alive.
Time frame: up to 85 months of follow-up
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