Phase II Trial of Gemcitabine And Docetaxel In Androgen-Independent Metastatic Prostate Cancer
- Determine the objective response rate and toxicity in patients with
androgen-independent metastatic prostate cancer treated with gemcitabine hydrochloride
OUTLINE: This is an open-label study.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 followed by
docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 5
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective PSA Response Rate (Number of Patients With a PSA Response)
Decline from a baseline value by ≥ 50% or normalization of PSA (< 0.03) confirmed by a second measurement at least 1 week or more weeks later. Patients must not demonstrate clinical or radiographic evidence of disease progression during this time period. The date of response will be defined as the first date at which the PSA declined from baseline by ≥ 50% or normalized.
every 4 weeks
Robert Dreicer, MD, FACP
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Federal Government
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|