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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: | NCT00070369 |
RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide may fight prostate cancer by reducing the production of testosterone. Some tumors become resistant to hormone therapy. Alternating short schedules of testosterone and leuprolide combined with a chemotherapy drug, such as docetaxel, may reduce resistance to the hormone therapy and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving testosterone and leuprolide together with docetaxel works in treating patients with recurrent or metastatic adenocarcinoma of the prostate (prostate cancer).
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: docetaxel Drug: leuprolide acetate Drug: therapeutic testosterone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Docetaxel With Rapid Hormonal Cycling As A Treatment For Patients With Prostate Cancer |
Study Start Date: | July 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to clinical state (rising prostate-specific antigen vs non-castrate metastatic disease).
Patients receive leuprolide intramuscularly and docetaxel IV over 1 hour on day 1 and testosterone gel topically on days 22-28. Treatment repeats every 28 days for 6 courses* in the absence of disease progression or unacceptable toxicity.
NOTE: *Testosterone gel is applied only during courses 1-5.
Patients are followed monthly for 1 year and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 76 patients (38 per stratum) will be accrued for this study within approximately 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate in either of the following clinical states:
History of localized disease with prior definitive radiotherapy or surgery
Radiographically evident non-castrate metastatic disease at the time of diagnosis or after treatment for localized disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 7 days since prior inhibitors or inducers of CYP3A, including the following:
No concurrent administration of the following drugs:
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Dana Rathkopf, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000331936, MSKCC-03076 |
Study First Received: | October 3, 2003 |
Last Updated: | July 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00070369 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate recurrent prostate cancer stage IV 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 Carcinoma Docetaxel Anabolic Agents Testosterone Leuprolide Adenocarcinoma Prostatic Neoplasms Androgens Neoplasms, Glandular and Epithelial |
Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Reproductive Control Agents Hormones Docetaxel Neoplasms by Site Leuprolide Therapeutic Uses Neoplasms by Histologic Type Antineoplastic Agents, Hormonal |
Methyltestosterone Genital Diseases, Male Pharmacologic Actions Testosterone 17 beta-cypionate Carcinoma Testosterone Neoplasms Anabolic Agents Fertility Agents, Female Fertility Agents Adenocarcinoma Prostatic Neoplasms Neoplasms, Glandular and Epithelial Androgens |