Carboplatin With or Without Thalidomide in Treating Patients With Ovarian Epithelial Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of ovarian cancer by stopping blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with thalidomide works compared to carboplatin alone in treating patients with ovarian epithelial cancer.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Study Comparing Carboplatin and Thalidomide With Carboplatin Alone in Patients With Stage Ic - IV Ovarian Cancer|
- Safety [ Designated as safety issue: Yes ]
- Response [ Designated as safety issue: No ]
- Markers of angiogenesis [ Designated as safety issue: No ]
|Study Start Date:||August 1999|
- Determine the safety of carboplatin and thalidomide in patients with stage IC-IV ovarian cancer.
- Determine the antiangiogenic effect of thalidomide in this patient population.
- Compare the efficacy of carboplatin with or without thalidomide in this patient population.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive carboplatin IV over 1 hour. Treatment continues every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive carboplatin as in arm I. Patients receive thalidomide orally once daily. Thalidomide treatment continues for up to 24 weeks commencing on the first day of carboplatin therapy and ceasing 4 weeks after the last course of carboplatin.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004876
|Oxford Radcliffe Hospital|
|Oxford, England, United Kingdom, 0X3 9DU|
|Study Chair:||T.S. Ganesan, MD||Oxford University Hospitals NHS Trust|