Estramustine, Etoposide and Paclitaxel Treatment for Hormonally Responsive Adenocarcinoma of the Prostate
Recruitment status was Active, not recruiting
Hormonal therapy is the standard treatment for prostate cancer which has spread to other areas of the body. Despite the high initial response rates to hormonal therapy, the vast majority of men will develop cancer which is no longer responsive to hormone deprivation. The average time for hormonal therapy to be effective is about 18 months. Chemotherapy combinations which can treat the disease when it no longer responds to hormonal therapy have been developed, but these treatments are not curative. One of these combinations is estramustine, etoposide and paclitaxel. In men with far advanced disease, 60% will have a decrease in their PSA or shrinkage of tumors after treatment with this chemotherapy. Despite this, these men have all developed further disease progression requiring additional treatment. One possible way to make chemotherapy more effective is to give it when the number of tumor cells is smallest, and the number of cells to be killed is at a low level. One situation in which this is true is when a man has responded to hormonal therapy any tumors are at their smallest size. This study will test whether the addition of chemotherapy at that time will prolong the time until the cancer becomes unresponsive to hormonal therapy.
Drug: Oral Estramustine, Oral Etoposide, Intravenous Paclitaxel
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Patients With Hormonally Responsive Adenocarcinoma of the Prostate|
- Estimate the time to treatment failure in patients treated with combined androgen blockade and 4 cycles of estramustine, etoposide and paclitaxel.
- Determine the overall survival in patients treated with combined androgen blockade and 4 cycles of estramustine, etoposide and paclitaxel.
- To evaluate the type, frequency and severity of toxicity in this patient population.
|Study Start Date:||December 1998|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151060
|United States, Michigan|
|The University of Michigan Comprehensive Cancer|
|Ann Arbor, Michigan, United States|
|Principal Investigator:||David C. Smith, MD||The University of Michigan Comprehensive Cancer Center|