Evaluation of Primary Chemotherapy With Docetaxel Plus Capecitabine in Selected Patients With Newly Diagnosed Localized or Locally Advanced Prostate Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Prostate Cancer
Both
Prostate Cancer
Trial Information
Evaluation of Primary Chemotherapy With Docetaxel Plus Capecitabine in Selected Patients With Newly Diagnosed Localized or Locally Advanced Prostate Cancer
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the response rate associated with capecitabine and docetaxel combination chemotherapy in selected patients with localized or locally advanced prostate cancer.
Principal Investigator
Maha Hussain, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The University of Michigan Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
UMCC 2-42
NCT ID:
NCT00151047
Start Date:
March 2003
Completion Date:
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Wayne State University | Detroit, Michigan 48202 |
| The University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109 |
