Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
|Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma||Drug: Carboplatin Drug: Paclitaxel Drug: Sorafenib Tosylate||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria [ Time Frame: after 6 weeks (2 cycles) ]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.
- Evaluate the Progression-free Survival Rate [ Time Frame: every 2 cycles (6 weeks) ]At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- Overall Survival [ Time Frame: 2 years ]Overall survival time is calculated from the date of treatment to date of death, and to date of last follow-up for those still alive.
|Study Start Date:||August 2004|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm I (closed to accrual 10/10/2008)
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
Drug: Sorafenib Tosylate
Experimental: 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.
Other Names:Drug: Paclitaxel
Other Names:Drug: Sorafenib Tosylate
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096200
|United States, Florida|
|Moffitt Cancer Center at Tampa General Hospital|
|Tampa, Florida, United States, 33612|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|Lake University Ireland Cancer Center|
|Mentor, Ohio, United States, 44060|
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Steven Waggoner||Case Comprehensive Cancer Center|