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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
docetaxel
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel

Arm Description

Docetaxel given via iv at determined dose once a week for 4 weeks

Outcomes

Primary Outcome Measures

Complete Response Rate
Wilcoxon Signed Rank Test

Secondary Outcome Measures

Percentage of Participants with mild to moderate toxicity

Full Information

First Posted
April 6, 2000
Last Updated
July 12, 2017
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI), Rhone-Poulenc Rorer
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1. Study Identification

Unique Protocol Identification Number
NCT00005096
Brief Title
Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer
Official Title
Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 1999 (Actual)
Primary Completion Date
June 2002 (Actual)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI), Rhone-Poulenc Rorer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel
Arm Type
Experimental
Arm Description
Docetaxel given via iv at determined dose once a week for 4 weeks
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
Taxotere
Primary Outcome Measure Information:
Title
Complete Response Rate
Description
Wilcoxon Signed Rank Test
Time Frame
2 Months, 6 Months
Secondary Outcome Measure Information:
Title
Percentage of Participants with mild to moderate toxicity
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary-Ellen Taplin, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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