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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00039221 |
Purpose
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as ketoconazole may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining ketoconazole with docetaxel may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining ketoconazole with docetaxel in treating patients who have metastatic prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: docetaxel Drug: ketoconazole |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Trial Of High Dose Ketoconazole Plus Weekly Docetaxel In Metastatic Androgen Independent Prostate Cancer |
| Estimated Enrollment: | 55 |
| Study Start Date: | April 2002 |
| Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of docetaxel.
Patients receive docetaxel IV over 1 hour once weekly on days 1, 8, and 18 and oral ketoconazole three times daily on days 15-28 for the first course. For the second and subsequent courses, patients receive docetaxel IV on days 1, 8, and 15 and oral ketoconazole daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel 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 toxicity.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: Approximately 3-55 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Progression during hormonal ablation (e.g., luteinizing-hormone releasing-hormone [LHRH] agonist therapy) defined as at least 1 of the following:
If no prior surgical castration, all of the following criteria must be met:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Maryland | |
| NCI - Center for Cancer Research | |
| Bethesda, Maryland, United States, 20892-8200 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Principal Investigator: | William Dahut, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000069364, NCI-02-C-0149 |
| Study First Received: | June 6, 2002 |
| Last Updated: | June 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00039221 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV prostate cancer recurrent prostate cancer |
|
Anti-Infective Agents Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Urogenital Neoplasms Genital Diseases, Male Ketoconazole |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Antifungal Agents Therapeutic Uses Prostatic Neoplasms |