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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00151060
First received: September 6, 2005
Last updated: January 19, 2015
Last verified: January 2015
  Purpose
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.

Condition Intervention Phase
Prostate Cancer
Drug: Estramustine
Drug: Etoposide
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Time to treatment failure [ Time Frame: 4 Cycles ] [ Designated as safety issue: No ]
    Estimate the time to treatment failure in patients treated with combined androgen blockade and 4 cycles of estramustine, etoposide and paclitaxel.


Enrollment: 28
Study Start Date: December 1998
Study Completion Date: June 2006
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Estramustine, Etoposide and Paclitaxel Drug: Estramustine Drug: Etoposide Drug: Paclitaxel

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

All patients must have a histologic diagnosis of adenocarcinoma of the prostate with evidence of metastases on bone or CT scan. Patients with regional metastases to pelvic lymph nodes (D1 disease) as their only site of metastases will be excluded from this study.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151060

Locations
United States, Michigan
The University of Michigan Comprehensive Cancer
Ann Arbor, Michigan, United States
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: David C. Smith, MD The University of Michigan Comprehensive Cancer Center
  More Information

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00151060     History of Changes
Other Study ID Numbers: UMCC 9815 
Study First Received: September 6, 2005
Last Updated: January 19, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Paclitaxel
Etoposide
Etoposide phosphate
Albumin-Bound Paclitaxel
Estramustine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on August 25, 2016