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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005096
First Posted: March 4, 2004
Last Update Posted: July 14, 2017
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.
Collaborators:
National Cancer Institute (NCI)
Rhone-Poulenc Rorer
Information provided by (Responsible Party):
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
  Purpose

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.


Condition Intervention Phase
Prostate Cancer Drug: docetaxel Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Complete Response Rate [ Time Frame: 2 Months, 6 Months ]
    Wilcoxon Signed Rank Test


Secondary Outcome Measures:
  • Percentage of Participants with mild to moderate toxicity [ Time Frame: 6 months ]

Enrollment: 19
Actual Study Start Date: December 1999
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel
Docetaxel given via iv at determined dose once a week for 4 weeks
Drug: docetaxel
Other Name: Taxotere

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00005096


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Rhone-Poulenc Rorer
Investigators
Principal Investigator: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Mary-Ellen Taplin, MD, Taplin, Mary-Ellen, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00005096     History of Changes
Other Study ID Numbers: 99-193
P30CA006516 ( U.S. NIH Grant/Contract )
DFCI-99193
NCI-G00-1757
First Submitted: April 6, 2000
First Posted: March 4, 2004
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute:
adenocarcinoma of the prostate
stage II prostate cancer
stage III prostate cancer

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