Ovarian Cancer Clinical Trial
Official title:
A Randomized Study Comparing Carboplatin and Thalidomide With Carboplatin Alone in Patients With Stage Ic - IV Ovarian 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.
OBJECTIVES:
- 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.
;
Allocation: Randomized, Primary Purpose: Treatment
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