Trials / Completed

CompletedNCT00003781

Docetaxel in Treating Patients With Stage IV Prostate Cancer

Phase II Study of Weekly Docetaxel (Taxotere) in Hormone Refractory Metastatic Prostate Cancer

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 25 (actual)

Sponsor: OHSU Knight Cancer Institute · Academic / Other
Sex: Male
Age: 18 Years – 120 Years
Healthy volunteers: Not accepted

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 of docetaxel in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.

Detailed description

OBJECTIVES: I. Evaluate the efficacy of weekly docetaxel as measured by disease response, strength and duration of pain reduction, and either a decrease in analgesic use without an increase in pain, or a decrease in PSA, in patients with hormone refractory metastatic prostate cancer. II. Assess the efficacy of this regimen in terms of survival in this patient population. III. Evaluate the effect of this regimen on quality of life in these patients. IV. Determine qualitative and quantitative toxicities of this regimen in these patients. OUTLINE: Patients receive docetaxel IV over 15-30 minutes weekly for 6 weeks. Courses repeat every 8 weeks. Therapy continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at weeks 1, 3, 5, and 7 of each course, and a daily pain medication diary is maintained during treatment. Patients are followed for 1 month or until resolution of toxicity, then every 3 months until death. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Conditions

Interventions

Type	Name	Description
DRUG	docetaxel
PROCEDURE	pain therapy
PROCEDURE	quality-of-life assessment

Timeline

Start date: 1998-12-01
Primary completion: 2003-06-01
Completion: 2003-06-01
First posted: 2004-07-22
Last updated: 2017-04-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00003781. Inclusion in this directory is not an endorsement.