Status:
COMPLETED
Docetaxel Plus Capecitabine in Newly Diagnosed Localized or Locally Advanced Prostate Cancer
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Prostate Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Purpose: The purpose of this clinical trial is to look at the chemotherapy combination of docetaxel and capecitabine in the treatment of newly diagnosed or locally advanced prostate cancer, and to det...
Eligibility Criteria
Inclusion
- Patients must have newly diagnosed prostate cancer with at least one of the following criteria:
- Clinical Stage \> T2
- PSA \> 15 ng/ml
- Biopsy Gleason's sum \> 8
- All patients must have a minimum PSA value of \> 5 ng/ml.
- Patients may not have evidence of distant systemic metastasis.
- Patients may not undergo concurrent hormonal, biologic, or chemotherapy.
- Patients may not have prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
- Patients with a history of severe reaction to docetaxel or other drugs formulated with polysorbate 80 will not be eligible.
- Patients may not have an underlying cardiac disease.
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00151047
Start Date
March 1 2003
End Date
October 1 2007
Last Update
January 21 2015
Active Locations (2)
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1
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
2
Wayne State University
Detroit, Michigan, United States