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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005627
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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
Prostate Cancer Drug: carboplatin Drug: docetaxel Drug: estramustine phosphate sodium Phase 1

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
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 : March 1999
Actual Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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)



  • 18 to 85

Performance status:

  • CALGB 0-2

Life expectancy:

  • Not specified


  • WBC at least 3,000/mm3
  • Platelet count at least 100,000/mm3


  • 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


  • Creatinine no greater than 2.0 mg/dL


  • 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


  • No significant peripheral neuropathy


Biologic therapy:

  • Not specified


  • Prior chemotherapy allowed except taxanes or platinum derivatives

Endocrine therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior antiandrogens


  • At least 4 weeks since prior radiotherapy


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005627

United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: William Oh, MD Dana-Farber Cancer Institute

Publications of Results: Identifier: NCT00005627     History of Changes
Other Study ID Numbers: DFCI-98238
CDR0000067775 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: April 2003

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Hormonal