A Phase II Trial Of BAY 43-9006, A Novel Raf Kinase Inhibitor Plus Paclitaxel/Carboplatin In Women With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
after 6 weeks (2 cycles)
Case Western Reserve University
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|