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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006044 |
RATIONALE: High doses of testosterone may be effective in killing prostate cancer cells that no longer respond to hormone therapy.
PURPOSE: Phase I trial to study the effectiveness of testosterone in treating patients who have progressive prostate cancer that no longer responds to hormone therapy.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: therapeutic testosterone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial of Testosterone in Patients With Progressive Androgen-Independent Prostate Cancer |
Study Start Date: | February 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive testosterone via an enhanced absorption transdermal system continuously for 28 days. The transdermal patches are changed daily.
Cohorts of 3-6 patients receive a fixed daily dose of testosterone with escalating duration of exposure until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities.
Patients are followed at day 1 and at weeks 2 and 4.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Progressive disease manifested by either:
Castrate state by orchiectomy or gonadotropin-releasing hormone analogues for minimum of 1 year
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Michael Morris, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000068060, MSKCC-99115, NCI-G00-1818 |
Study First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006044 History of Changes |
Health Authority: | United States: Federal Government |
stage IV prostate cancer recurrent prostate cancer |
Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Methyltestosterone Genital Diseases, Male |
Hormones Recurrence Testosterone 17 beta-cypionate Anabolic Agents Testosterone Prostatic Neoplasms Androgens |
Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Methyltestosterone Genital Diseases, Male Hormones |
Pharmacologic Actions Testosterone 17 beta-cypionate Anabolic Agents Neoplasms Testosterone Neoplasms by Site Therapeutic Uses Prostatic Neoplasms Androgens |