A Randomized Study Comparing Carboplatin and Thalidomide With Carboplatin Alone in Patients With Stage Ic - IV Ovarian 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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Safety
Yes
T.S. Ganesan, MD
Study Chair
Oxford Radcliffe Hospital
Unspecified
CDR0000067536
NCT00004876
August 1999
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