Overview

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

Status:
Completed
Trial end date:
2002-06-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborators:
National Cancer Institute (NCI)
Rhone-Poulenc Rorer
Treatments:
Docetaxel
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