Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer
- Registration Number
- NCT00258284
- Lead Sponsor
- Barbara Ann Karmanos Cancer Institute
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel works in treating patients with metastatic prostate cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine the response rate in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with capecitabine and docetaxel.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Docetaxel & Capecitabine capecitabine 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 Docetaxel & Capecitabine docetaxel 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
- Primary Outcome Measures
Name Time Method Response rate by RECIST criteria after every 2 courses at cycle 2 and every other cycle thereafter
- Secondary Outcome Measures
Name Time Method Toxicity at 30 days after last treatment Every week during treatment cycles Progression-free survival Every 2 cycles Time to treatment failure Every 2 cycles From date of registration to date of progressive disease, or date patient is taken off study for any other reason.
Overall survival Every 2 cycles Effect of treatment on biological correlates (thymidine phosphorylase, dihydropyrimidine dehydrogenase, thymidylate synthase) Every week during treatment cycles
Trial Locations
- Locations (1)
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States