Estramustine, Etoposide and Paclitaxel Treatment for Hormonally Responsive Adenocarcinoma of the Prostate

NCT ID: NCT00151060

Last Updated: 2015-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-12-31
• Study Completion Date: 2006-06-30

Brief Summary

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 (Prostate Specific Antigen) 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Estramustine, Etoposide and Paclitaxel

Group Type: EXPERIMENTAL

Estramustine

Intervention Type: DRUG

Etoposide

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Interventions

Estramustine

Intervention Type: DRUG

Etoposide

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

Patients on androgen suppression therapy at the time of registration must have received less than seven months of therapy (excluding any neoadjuvant hormonal therapy) and must have a decreasing or stable PSA level.

Patients may not be undergoing concurrent chemotherapy, biologic therapy, or radiation therapy. Prior to radiation therapy must have completed more than 4 weeks prior to registration.

Patients may not have received prior cytotoxic chemotherapy.

Patients may not have evidence of brain metastases or untreated spinal cord compression.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David C. Smith, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Michigan Comprehensive Cancer Center

Locations

The University of Michigan Comprehensive Cancer

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

UMCC 9815

Identifier Type: -

Identifier Source: org_study_id