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

NCT ID: NCT00005096

Last Updated: 2017-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2002-06-30

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Docetaxel

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

Group Type EXPERIMENTAL

docetaxel

Intervention Type DRUG

Interventions

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docetaxel

Intervention Type DRUG

Other Intervention Names

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Taxotere

Eligibility Criteria

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Exclusion Criteria

* No prior hormones, radiation or chemotherapy for prostate cancer
* Evidence of serious active infection
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Rhone-Poulenc Rorer

INDUSTRY

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Mary-Ellen Taplin, MD

Taplin, Mary-Ellen

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary-Ellen Taplin, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA006516

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DFCI-99193

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1757

Identifier Type: -

Identifier Source: secondary_id

99-193

Identifier Type: -

Identifier Source: org_study_id

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