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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005096
  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 II

MedlinePlus related topics:   Cancer    Prostate Cancer   

Drug Information available for:   Docetaxel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   December 1999

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
Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005096

Locations
United States, Massachusetts
Brigham and Women's Hospital    
      Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute    
      Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center    
      Boston, Massachusetts, United States, 02114

Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     William Oh, MD     Dana-Farber Cancer Institute    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067764, DFCI-99193, NCI-G00-1757
First Received:   April 6, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005096
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate  
stage II prostate cancer  
stage III prostate cancer  

Study placed in the following topic categories:
Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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