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

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ClinicalTrials.gov Identifier: NCT00151086
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : January 22, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Michigan Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: Estramustine Drug: Vinorelbine Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2001
Primary Completion Date : March 2004
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Estramustine and Vinorelbine
Treatment will consist of 28-day cycles with estramustine at a dose of 140mg orally 3 times per day on days 1-3 and 8-10 and vinorelbine orally on days 2 and 9 beginning at dose 50mg/m^2.
Drug: Estramustine Drug: Vinorelbine



Primary Outcome Measures :
  1. Tolerable Dose of Vinorelbine in Combination with Estramustine [ Time Frame: 180 days post dose ]
    To determine the tolerable dose of oral vinorelbine in combination with oral estramustine on an intermittent schedule, and describe the toxicities of the regimen. The dose will not be escalated until at least 180 days of cumulative observation of acute toxicity in patients enrolled at a particular dose level.



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

Inclusion:

  • 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 (Prostate Specific Antigen) 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). If PSA is the only evidence of progressive disease it must be greater than or equal to 4ng/mL.
  • Adequate bone marrow, renal and liver function
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (a measure of general well being on a scale of 0-5 where 0 represents asymptomatic and 5 represents death)
  • Must be at least 18 years of age
  • Must have a life expectancy of greater than or equal to 12 weeks

Exclusion:

  • Have previously received vinca alkaloid-based cytotoxic chemotherapy or radiation to greater than or equal to 50% of the total bone marrow.
  • Evidence of brain metastasis
  • Spinal cord compression
  • Prior malignancy except for in situ carcinoma, nonmelanoma skin cancer, or adequately treated malignancy that has been inactive for less than 3 years
  • Patients with preexisting neuropathy of greater than or equal to grade 2
  • Active gastrointestinal disease, or a disorder that alters gastrointestinal motility or absorption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151086


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

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00151086     History of Changes
Other Study ID Numbers: UMCC 2001-050
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Vinorelbine
Vinblastine
Estramustine
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Hormonal