A Phase 1 interventional study of docetaxel and estramustine phosphate sodium in Prostate Cancer, sponsored by Herbert Irving Comprehensive Cancer Center. Status unknown at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-19.
Sponsored by Herbert Irving Comprehensive Cancer Center · Phase 1, Interventional, and Treatment
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.
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's planned enrollment of 12 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Herbert Irving Comprehensive Cancer Center is the lead sponsor of 33 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
This study is status unknown, as verified in Mar 2005. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Docetaxel · Estramustine · Mitoxantrone · Prednisone
Herbert Irving Comprehensive Cancer Center