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

July 17, 2013 updated by: Dana-Farber Cancer Institute

A Phase I Study of Estramustine, Taxotere and Carboplatin (ETP) in Patients With Horomone Refractory Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1999

Study Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 18, 2013

Last Update Submitted That Met QC Criteria

July 17, 2013

Last Verified

April 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFCI-98238
  • CDR0000067775 (Registry Identifier: PDQ (Physician Data Query))
  • RP-DFCI-98238
  • NCI-G00-1779

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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