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

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: carboplatin; Drug: estramustine phosphate sodium; Drug: docetaxel

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00005627

RP-DFCI-98238

CDR0000067775 (Registry Identifier)

DFCI-98238

NCI-G00-1779

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Determine the maximum tolerated dose of weekly docetaxel when combined with carboplatin and estramustine in patients with hormone refractory prostate cancer.
• Determine the safety and efficacy of this regimen in this patient population.

OUTLINE: This is a dose escalation study of docetaxel.

Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 2 of weeks 1-3. Patients also receive carboplatin IV over 1 hour on day 2 of week 1 only. Treatment continues every 28 days for up to 6 courses in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 12 months.

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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