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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00005096

Enrollment

Registered

2004-03-04

Start date

1999-12-31

Completion date

2002-06-30

Last updated

2017-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage II prostate cancer, stage III 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.

Interventions

DRUGdocetaxel

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Complete Response Rate	2 Months, 6 Months	Wilcoxon Signed Rank Test

Secondary

Measure	Time frame
Percentage of Participants with mild to moderate toxicity	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026