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

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: docetaxel

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00005096

DFCI-99193

P30CA006516 (U.S. NIH Grant/Contract)

99-193

NCI-G00-1757

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Docetaxel

Experimental group

Description:

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

Treatment:

Drug: docetaxel