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

NCT ID: NCT00005627

Last Updated: 2013-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-03-31
• Study Completion Date: 2003-04-30

Brief 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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

carboplatin

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

estramustine phosphate sodium

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Principal Investigators

William Oh, MD

Role: STUDY_CHAIR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

Oh WK, Hagmann E, Manola J, George DJ, Gilligan TD, Jacobson JO, Smith MR, Kaufman DS, Kantoff PW. A phase I study of estramustine, weekly docetaxel, and carboplatin chemotherapy in patients with hormone-refractory prostate cancer. Clin Cancer Res. 2005 Jan 1;11(1):284-9.

Reference Type: RESULT

PMID: 15671557 (View on PubMed)

Other Identifiers

CDR0000067775

Identifier Type: REGISTRY

Identifier Source: secondary_id

RP-DFCI-98238

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1779

Identifier Type: -

Identifier Source: secondary_id

DFCI-98238

Identifier Type: -

Identifier Source: org_study_id