Phase II Trial of Capecitabine (Xeloda) and Weekly Docetaxel (Taxotere) in Metastatic Androgen Independent Prostate Carcinoma
- Determine the response rate in patients with androgen-independent metastatic
adenocarcinoma of the prostate treated with capecitabine and docetaxel.
- Determine the toxicity of this regimen in these patients.
- Determine the progression-free survival, time to treatment failure, and overall
survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine
twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression
or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional
courses of therapy beyond CR
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate by RECIST criteria after every 2 courses
at cycle 2 and every other cycle thereafter
Ulka N. Vaishampayan, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|