Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer
RATIONALE: Drugs such as thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating women who have epithelial ovarian cancer that has not responded to previous therapy.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial of Thalidomide in Patients With Ovarian Cancer|
|Study Start Date:||January 2001|
|Study Completion Date:||March 2004|
|Primary Completion Date:||March 2004 (Final data collection date for primary outcome measure)|
- Determine the time to progression of disease in patients with platinum-refractory or resistant ovarian epithelial carcinoma treated with thalidomide.
- Evaluate the quality of life of patients treated with this regimen.
OUTLINE: Patients receive oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 4 weeks.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 9-15 months.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||David R. Spriggs, MD||Memorial Sloan-Kettering Cancer Center|