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

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00005627
Collaborator
National Cancer Institute (NCI) (NIH)
2
Locations
49
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Phase I Study of Estramustine, Taxotere and Carboplatin (ETP) in Patients With Horomone Refractory Prostate Cancer
Study Start Date :
Mar 1, 1999
Actual Study Completion Date :
Apr 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    2 Dana-Farber Cancer Institute Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Dana-Farber Cancer Institute
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: William Oh, MD, Dana-Farber Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00005627
    Other Study ID Numbers:
    • DFCI-98238
    • CDR0000067775
    • RP-DFCI-98238
    • NCI-G00-1779
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jul 18, 2013
    Last Verified:
    Apr 1, 2003
    Keywords provided by , ,
    adenocarcinoma of the prostate
    recurrent prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Carboplatin
    Docetaxel
    Estramustine

    Study Results

    No Results Posted as of Jul 18, 2013