Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

• Status: Completed
• Trial end date: 2003-04-01
• 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 trial to study the effectiveness of estramustine, docetaxel, and carboplatin in treating patients who have prostate cancer that has not responded to hormonal therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Docetaxel; Estramustine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Disease progression following androgen ablation therapy (hormonal or surgical) by either:

• Increase in the product of bidimensional diameters of 1 or more radiographically documented sites of measurable disease OR

• Two consecutive increases in PSA documented over a previous reference value

• First increase in PSA should occur a minimum of 1 week from the reference value and be confirmed

• First PSA value is less than the previous value, then patient is eligible provided next PSA is greater than the second PSA

• Testosterone levels documented in the castrate range (i.e., less than 30 ng/mL)

PATIENT CHARACTERISTICS:

Age:

• 18 to 85

Performance status:

• CALGB 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin normal

• SGOT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase normal OR

• Alkaline phosphatase no greater than 4 times ULN if SGOT normal OR

• SGOT no greater than 1.5 times ULN and alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No myocardial infarction within past year

• No significant change in anginal pattern within past 6 months

• No New York Heart Association class II-IV heart disease

• No deep venous thrombosis within past year

Other:

• No significant peripheral neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Prior chemotherapy allowed except taxanes or platinum derivatives

Endocrine therapy:

• See Disease Characteristics

• At least 4 weeks since prior antiandrogens

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• See Disease Characteristics