Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer

July 12, 2017 updated by: Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute

Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have stage II or stage III prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the pathologic complete response rate to docetaxel in patients with high risk stage II or III prostate cancer. II. Determine the toxicity of this treatment in these patients. III. Correlate clinical measures of response (e.g., symptoms, physical exam, serum PSA, and endorectal MRI) with pathologic response to this treatment in these patients.

OUTLINE: Patients receive docetaxel IV over 30 minutes weekly for 4 weeks. Treatment continues for 2-6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 19-45 patients will be accrued for this study over 18 months.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

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
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Eligibility Criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Potential candidate for radical prostatectomy

  • Any of the following:

    • Clinical stage T3 patients
    • Serum PSA at least 20 ng/mL
    • Gleason score 8-10

    • Clinical T2 disease and either of the following:

      • MRI evidence of seminal vesicle involvement
      • Gleason 4+3 cancer with either 5 or 6 biopsies positive
  • CALGB 0-1
  • WBC greater than 3,000/mm3
  • Hematocrit greater than 30%
  • Platelet count greater than 100,000/mm3
  • SGOT, total bilirubin within normal limits
  • Signed Informed consent

Exclusion Criteria:

  • No prior hormones, radiation or chemotherapy for prostate cancer
  • Evidence of serious active infection

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
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Docetaxel
Docetaxel given via iv at determined dose once a week for 4 weeks
Drug: docetaxel
Other Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate
Time Frame: 2 Months, 6 Months
Wilcoxon Signed Rank Test
2 Months, 6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with mild to moderate toxicity
Time Frame: 6 months
6 months

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)
Rhone-Poulenc Rorer

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 (Actual)

December 1, 1999

Primary Completion (Actual)

June 1, 2002

Study Completion (Actual)

June 1, 2002

Study Registration Dates

First Submitted

April 6, 2000

First Submitted That Met QC Criteria

March 3, 2004

First Posted (Estimate)

March 4, 2004

Study Record Updates

Last Update Posted (Actual)

July 14, 2017

Last Update Submitted That Met QC Criteria

July 12, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99-193
  • P30CA006516 (U.S. NIH Grant/Contract)
  • DFCI-99193
  • NCI-G00-1757

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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