Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Randomized Study of Paclitaxel, Etoposide, and Estramustine Versus Ketoconazole, Doxorubicin, Vinblastine, and Estramustine in Patients With Androgen Independent Prostate Cancer (Summary Last Modified 02/2001)

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	MDA-DM-97022 NCI-T97-0023, NCT00003084, T97-0023

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Randomized phase II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, etoposide, and estramustine as compared with ketoconazole plus doxorubicin, vinblastine, and estramustine in treating patients with prostate cancer.

Eligibility:

• At least 18 years old
• Rising PSA levels
• No previous ketoconazole, doxorubicin, vinblastine, estramustine, paclitaxel or etoposide
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomized to one of two groups. Patients in group one will receive estramustine by mouth three times a day, etoposide by mouth twice a day for 2 weeks, plus an infusion of paclitaxel on day 2. Treatment may be repeated every 3 weeks for as long as benefit is shown. Patients in group two will receive an infusion of doxorubicin on days 1, 15, and 29 and an infusion of vinblastine on days 8, 22, and 36. They will also receive ketoconazole by mouth three times a day on days 1-7, 15-21, and 29-35 plus estramustine by mouth twice a day on days 8-14, 22-28, and 36-42. Treatment may be repeated every 8 weeks for as long as benefit is shown.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Randall Millikan, MD, PhD, Protocol chair		Ph: 713-563-7245; 800-392-1611 Email: rmillika@mdanderson.org

Registry Information
Official Title		A Randomized Phase II Trial of Taxol/VP-16/Estramustine vs. Ketoconazole/Doxorubicin/Vinblastine/Estramustine in Androgen Independent Prostate Cancer
Trial Start Date		1997-12-10
Registered in ClinicalTrials.gov		NCT00003084
Date Submitted to PDQ		1997-09-12
Information Last Verified		2007-05-14

Back to Top