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| Sponsors and Collaborators: |
University of Michigan GlaxoSmithKline |
|---|---|
| Information provided by: | University of Michigan |
| ClinicalTrials.gov Identifier: | NCT00151086 |
Purpose
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 I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2001 |
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.
Eligibility| 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| United States, Michigan | |
| The University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: | David C. Smith, MD | The University of Michigan Comprehensive Cancer Center |
More Information
| Study ID Numbers: | UMCC 2001-050 |
| Study First Received: | September 6, 2005 |
| Last Updated: | September 6, 2005 |
| ClinicalTrials.gov Identifier: | NCT00151086 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents, Hormonal Estramustine Urogenital Neoplasms Genital Diseases, Male Hormones |
Vinorelbine Antineoplastic Agents, Alkylating Adenocarcinoma Prostatic Neoplasms Alkylating Agents Antineoplastic Agents, Phytogenic |
|
Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Estramustine Urogenital Neoplasms Genital Diseases, Male Pharmacologic Actions |
Neoplasms Neoplasms by Site Vinorelbine Therapeutic Uses Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents Prostatic Neoplasms |
