A Randomized Phase II Study of Paclitaxel/Carboplatin With or Without Sorafenib in the First-Line Treatment of Patients With Stage III/IV Epithelial Ovarian Cancer
All patients must be at least 4 weeks from cytoreductive surgery before starting treatment.
Patients will be randomized to receive treatment with either paclitaxel/carboplatin +
sorafenib or paclitaxel/carboplatin. Paclitaxel/carboplatin will be repeated every 21 days
for a maximum of 6 cycles. Patients with objective response/stable disease after completing
6 courses of chemotherapy will continue sorafenib until disease progression or for a total
of 12 months.
- Regimen A: Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over
20 minutes IV, Day 1 Sorafenib 400mg PO bid
- Regimen B: Paclitaxel 175mg/m2, 1-3 hour IV infusion, Day 1 Carboplatin AUC 6.0, 20 minute
IV infusion, Day 1
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
progression free survival
18 months
No
John D. Hainsworth, MD
Principal Investigator
Sarah Cannon Research Institute
United States: Institutional Review Board
SCRI GYN 19
NCT00390611
October 2006
July 2013
Name | Location |
---|---|
Northeast Arkansas Clinic | Jonesboro, Arkansas 72401-3125 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
South Carolina Oncology Associates, PA | Columbia, South Carolina 29210 |
Family Cancer Center | Collierville, Tennessee 38017 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Clearview Cancer Institute | Huntsville, Alabama 35805 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Gulfcoast Oncology Associates | St. Petersburg, Florida 33705 |
Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
Oncology Hematology Care | Cincinnati, Ohio 45242 |
Providence Medical Group | Terre Haute, Indiana 47802 |
Medical College of Georgia Cancer Specialists | Augusta, Georgia 30912 |