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Phase I/II Evaluation of Oral Estramustine and Oral Vinorelbine on an Intermittent Schedule in Patients With Hormone-Refractory Adenocarcinoma of the Prostate


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase I/II Evaluation of Oral Estramustine and Oral Vinorelbine on an Intermittent Schedule in Patients With Hormone-Refractory Adenocarcinoma of the Prostate


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.

Inclusion Criteria


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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

David C. Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Michigan Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

UMCC 2001-050

NCT ID:

NCT00151086

Start Date:

December 2001

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

The University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109