Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Oral Estramustine and Oral Vinorelbine in the Treatment of Hormone-Refractory Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University of Michigan.
Recruitment status was  Active, not recruiting
Information provided by:
University of Michigan Identifier:
First received: September 6, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

Purpose: This clinical trail will combine the chemotherapy drugs, Estramustine and Vinorelbine (Navelbine), on an intermittent therapy strategy based on PSA response in the treatment of hormone refractory prostate cancer. The investigators will determine the tolerable dose of (oral) vinorelbine in combination with (oral)estramustine, and evaluate the efficacy of this treatment for patients with hormone-refractory prostate cancer.

Condition Intervention Phase
Prostate Cancer
Drug: Oral Estramustine
Drug: Oral Vinorelbine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Evaluation of Oral Estramustine and Oral Vinorelbine on an Intermittent Schedule in Patients With Hormone-Refractory Adenocarcinoma of the Prostate

Resource links provided by NLM:

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • To determine the tolerable dose of oral vinorelbine in combination with oral estramustine on an intermittent schedule, and describe the toxicities of the regimen.

Estimated Enrollment: 30
Study Start Date: December 2001
Detailed Description:

Hormone Refractory prostate cancer refers to advanced disease in which a patient no longer responds to conventional hormonal treatment. When hormone therapy is no longer successful, chemotherapy is a treatment option. However, current single-agent treatment has shown to have limited benefit. In this clinical trial, investigators are evaluating the effectiveness of combining two chemotherapy drugs, Estramustine and Vinorelbine (Navelbine), in the treatment of hormone refractory prostate cancer. Estramustine has been used in the treatment of prostate cancer for many years. Vinorelbine has shown activity in prostate cancer. In addition, the effect of this treatment on the quality of life of patients will be evaluated as measured using the FACT-P.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Patients must have a histologic diagnosis of adenocarcinoma of the prostate. (No evidence of brain metastasis or untreated spinal cord compression.)

Patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate at rising PSA 4 weeks after withdrawal for flutamide and 6 weeks after withdrawal for bicalutamide or nilutamide.

Patients must have measurable soft tissue disease or evaluable (abnormal bone scan and/or elevated PSA).

  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 identifier: NCT00151086

United States, Michigan
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Principal Investigator: David C. Smith, MD The University of Michigan Comprehensive Cancer Center
  More Information

No publications provided Identifier: NCT00151086     History of Changes
Other Study ID Numbers: UMCC 2001-050
Study First Received: September 6, 2005
Last Updated: September 6, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 20, 2014