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Completed

NCT Number: NCT00151086

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estramustine

Drug

Vinorelbine

Drug

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2004
Study completion
2006
First posted
Sep 8, 2005
Registry last updated
Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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