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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005096
• Other study ID #: 99-193
• Secondary ID: P30CA006516DFCI-
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2000
• Last updated: July 12, 2017
• Start date: December 1999
• Est. completion date: June 2002

Study information

• Verified date: July 2017
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2002
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• docetaxel

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI), Rhone-Poulenc Rorer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response Rate	Wilcoxon Signed Rank Test	2 Months, 6 Months
Secondary	Percentage of Participants with mild to moderate toxicity		6 months