Study of Oxaliplatin and Taxotere in Androgen Independent Prostate Cancer
This is a single institution phase II study of oxaliplatin and Taxotere in patients with
androgen independent prostate cancer previously treated with up to two cytotoxic
chemotherapy regimens. During this study, the efficacy and safety of this combination will
be evaluated. The primary objective for this study is to evaluate PSA response rates
(response will be defined as a > 50% reduction in PSA levels) in men who have failed primary
chemotherapy. The secondary objectives are to compare progression free survival, disease
free survival, overall survival, and toxicity (tolerance/safety). There will be up to 35
male subjects >= 18 years of age enrolled on this single institution study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate PSA response rates (response will be defined as a > 50% reduction in PSA levels) in men who have failed primary chemotherapy.
Subjects once off treatment wil be followed for survival
Followed for survival
No
Leonard J Appleman, MD
Principal Investigator
University of Pittsburgh
United States: Institutional Review Board
04-011
NCT00260611
November 2004
September 2007
Name | Location |
---|---|
Hillman Cancer Center | Pittsburg, Pennsylvania 15232 |