Overview

Docetaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
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: Phase I/II trial to study the effectiveness of combining docetaxel and estramustine in treating patients who have metastatic prostate cancer.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Herbert Irving Comprehensive Cancer Center
Treatments:
Docetaxel
Estramustine
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the prostate
Failure of androgen ablation (orchiectomy or luteinizing hormone releasing hormone,
flutamide) -Rise in PSA greater than 50% of nadir confirmed by 2 measurements 1 week apart
-Appearance of new soft tissue lesions -Appearance of new lesions on bone scan Measurable
or evaluable disease No symptomatic ascites, pleural effusions, or peripheral edema greater
than trace No brain or leptomeningeal involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 No history of coagulopathy Hepatic: Bilirubin
no greater than upper limit of normal (ULN) SGOT or SGPT no greater than 2.0 times ULN
Alkaline phosphatase no greater than 5.0 times ULN Renal: Creatinine no greater than 2.0
times ULN Cardiovascular: No myocardial infarction within past 6 months Pulmonary: No prior
pulmonary embolus Neurologic: No prior cerebrovascular accident No symptomatic peripheral
neuropathy greater than grade 1 No significant neurologic or psychiatric disorder
(psychotic disorder, dementia, or seizure) Other: No other prior malignancy within past 5
years, except: Excised or curatively irradiated nonmelanomatous skin cancer No other
serious illness or medical condition No active infection

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal therapy
Radiotherapy: At least 4 weeks since prior radiotherapy At least 6 weeks since prior
isotope therapy No prior radiotherapy to greater than 30% of bone marrow Surgery: Not
specified Other: At least 4 weeks since prior investigational drugs