Docetaxel and Diethylstilbestrol in the Treatment of Androgen Independent Prostate Cancer
This study is for men who have prostate cancer that has spread outside of the prostate gland and is no longer responding to hormone removal therapy. This study is designed to determine if a new drug combination will help to control the cancer. The medicines being used, docetaxel and diethylstilbestrol (DES), have been given to patients with prostate cancer and each drug has demonstrated activity in prostate cancer, either used alone or in other combinations. The objective of this study is to determine the effect of this drug combination on the prostate cancer and its response to disease progression.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Docetaxel and Diethylstilbestrol in the Treatment of Androgen Independent Prostate Cancer: A Phase II Study|
- Monthly PSA levels and scans every 3 months while on therapy [ Time Frame: Over 10 months ]
- To evaluate the time to progression of disease [ Time Frame: Follow-up until progression ]
- To determine the risk of cardiovascular complications associated with DES plus aspirin and warfarin 2 mg daily [ Time Frame: Over 10 months while on therapy ]
- To measure this regimen's toxicity and impact on quality of life measures [ Time Frame: Over 10 months while on therapy ]
|Study Start Date:||December 2002|
|Study Completion Date:||October 2007|
Drug: Docetaxel and Diethylstilbestrol (DES)
This is a single arm phase II trial of docetaxel and diethylstilbestrol for patients with symptomatic stage D3 androgen independent prostate cancer. Patients will receive docetaxel weekly for 10 cycles (each cycle consists of treatment for 3 weeks out of every 4) and DES daily for 40 weeks or until there is evidence of disease progression, whichever occurs first. Patients will be followed to determine PSA and objective response. Additional endpoints include time to progression, disease specific survival and overall survival. Disease progression will be defined as 2 consecutive increases in PSA and/or tumor growth as evidenced by examination or radiologic evaluation. Other secondary objectives will be to determine the toxicity, and impact on quality of life of this regimen.