Evaluation of Primary Chemotherapy With Docetaxel Plus Capecitabine in Selected Patients With Newly Diagnosed Localized or Locally Advanced Prostate Cancer
Patients must have newly diagnosed prostate cancer with at least one of the following
- 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.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the response rate associated with capecitabine and docetaxel combination chemotherapy in selected patients with localized or locally advanced prostate cancer.
Maha Hussain, MD
The University of Michigan Comprehensive Cancer Center
United States: Institutional Review Board
- Prostate Cancer
- Prostatic Neoplasms
|Wayne State University||Detroit, Michigan 48202|
|The University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109|