Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

April 6, 2000

Last Updated Date

July 23, 2008

Start Date ^ICMJE

December 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00005096 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: docetaxel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS: 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

PATIENT CHARACTERISTICS: Age: 18 to 85 Performance status: CALGB 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Hematocrit greater than 30% Platelet count greater than 100,000/mm3 Hepatic: SGOT and bilirubin normal Renal: Not specified Other: No active infection Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for prostate cancer Endocrine therapy: No prior hormonal therapy for prostate cancer Radiotherapy: No prior radiotherapy for prostate cancer Surgery: See Disease Characteristics No prior surgery for prostate cancer

Gender

Male

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00005096

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067764, DFCI-99193, NCI-G00-1757

Study Sponsor ^ICMJE

Dana-Farber Cancer Institute

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

William Oh, MD

Dana-Farber Cancer Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

January 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP