Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258284
Status:
COMPLETED
Last Update Posted:
2014-03-06
First Post:
2005-11-22
Brief Title:
Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase II Trial of Capecitabine Xeloda and Weekly Docetaxel Taxotere in Metastatic Androgen Independent Prostate Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-D-2615 | None | None | None |
| WSU-HIC-067903MP4F | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |