Phase II Trial of Thalidomide and Doxil® (Doxorubicin HCL Liposome Injection) in Patients With Androgen Independent Prostate Cancer (AIPC) With a Rising PSA While on Chemotherapy
This is an open label, Phase II trial of thalidomide and Doxil in patients with androgen
independent prostate cancer whom have a rising PSA while on chemotherapy. The primary
objective of this study is to evaluate PSA response rates of the combination of Doxil and
Thalidomide in patients with AIPC who have failed chemotherapy. Secondary objectives
include: 1) To evaluate the clinical response rate of this combination on measurable disease
(If measurable soft tissue lesions are present on radiological or clinical exam) ; 2) To
evaluate overall survival for this combination. There will be between 18 and 35 subjects at
least 18 years of age enrolled on this single site study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate
24 weeks
No
Gurkamal S Chatta, MD
Principal Investigator
University of Pittsburgh
United States: Food and Drug Administration
05-078
NCT00307294
March 2006
January 2012
Name | Location |
---|---|
Hillman Cancer Center | Pittsburg, Pennsylvania 15232 |