Prostate Cancer Clinical Trial
Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer
Summary
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.
Full Description
OBJECTIVES:
Determine the maximum tolerated doses of docetaxel and mitoxantrone in combination with a fixed dose of estramustine and prednisone, when given to patients with advanced prostate cancer.
Characterize the toxicity of this treatment regimen in these patients.
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Failure of complete androgen ablation (orchiectomy or LHRH and antiandrogen therapy) as manifested by at least 1 of the following criteria:
Rise in serum PSA greater than 50% of nadir confirmed on 2 measurements 1 week apart
Appearance of new lesions on bone scan
Appearance of new soft-tissue lesions
Measurable or evaluable disease
No brain or leptomeningeal involvement
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
ECOG 0-2
Life expectancy:
Greater than 3 months
Hematopoietic:
WBC at least 3,500/mm3
Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3
Hepatic:
Bilirubin no greater than upper limit of normal (ULN)
Alkaline phosphatase no greater than 5 times ULN
SGOT and SGPT no greater than 2 times ULN
Renal:
Creatinine no greater than 2 times ULN
Cardiovascular:
No history of coagulopathy
No myocardial infarction in the last 6 months
No history of cardiovascular accident
No history of congestive heart failure
Neurological:
No symptomatic peripheral neuropathy greater than grade 1
No history of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures
Pulmonary:
No history of pulmonary embolus
Other:
Testosterone no greater than 3.5 nmol/L
No contraindications to glucocorticoid therapy such as uncontrolled diabetes mellitus or active peptic ulcer disease
No active infection
No other serious illness or medical condition
No other concurrent or prior malignancy in the past 5 years except previously excised or curatively irradiated nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
At least 4 weeks since prior chemotherapy
Endocrine therapy:
See Disease Characteristics
At least 4 weeks since prior hormonal therapy (including nonsteroidal antiandrogens, but not LHRH agonists)
Radiotherapy:
No prior radiotherapy to greater than 30% of bone marrow
At least 6 weeks since isotope therapy
At least 4 weeks since prior radiotherapy
Surgery:
See Disease Characteristics
Other:
At least 4 weeks since prior investigational drugs
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There is 1 Location for this study
New York New York, 10032, United States
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