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Sponsored by: |
Herbert Irving Comprehensive Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003633 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with advanced prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: docetaxel Drug: estramustine phosphate sodium Drug: mitoxantrone hydrochloride Drug: prednisone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Treatment of Prostate Cancer by Induction of Alternate Cell Death Pathways: A Phase I Trial of Docetaxel, Estramustine, Mitoxantrone and Prednisone |
Estimated Enrollment: | 12 |
Study Start Date: | August 1998 |
OBJECTIVES:
OUTLINE: This is a dose escalation study of mitoxantrone and docetaxel. Patients are stratified into one of two risk groups (good risk group or poor risk group) based on the number of prior chemotherapy regimen(s) and the occurrence and sites(s) of prior radiation.
All patients receive oral prednisone twice daily on days 0-3, oral estramustine three times daily on days 1-5, mitoxantrone IV bolus on day 2, and docetaxel IV over 1 hour on day 2. Courses repeat every 21 days in the absence of unacceptable toxicity and disease progression. Patients with stable disease may go off treatment after 6 courses.
Dose escalation proceeds independently for each risk group. Cohorts of 3 patients are entered into each risk group. If 1 of 3 patients at a dose level experiences dose limiting toxicity (DLT), then 3 additional patients are accrued into this level. If 2 of 6 patients at a dose level experience DLT, then dose escalation stops and the maximum tolerated dose (MTD) is defined at the previous dose level. At least 6 patients must be treated at the MTD.
Patients are followed every 3 months until death.
PROJECTED ACCRUAL: At least 12 patients (6 in each risk group) will be accrued into this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Failure of complete androgen ablation (orchiectomy or LHRH and antiandrogen therapy) as manifested by at least 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurological:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University | |
New York, New York, United States, 10032 |
Study Chair: | Daniel P. Petrylak, MD | Herbert Irving Comprehensive Cancer Center |
Study ID Numbers: | CDR0000066717, CPMC-IRB-8040, CPMC-IRB-8040-2/9173, NCI-V98-1487, CPMC-IRB-AAAA5741 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003633 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Docetaxel Prednisone Death Prostatic Diseases Genital Neoplasms, Male Estramustine |
Urogenital Neoplasms Mitoxantrone Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Glucocorticoids Pharmacologic Actions |
Neoplasms Neoplasms by Site Sensory System Agents Therapeutic Uses Antineoplastic Agents, Alkylating Analgesics Peripheral Nervous System Agents Central Nervous System Agents Alkylating Agents |