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Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

NCT00052845 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-07-01

No results posted yet for this study

Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Estramustine may fight prostate cancer by reducing the production of androgens. Exisulind may stop the growth of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining these therapies may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining estramustine with exisulind and docetaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Conditions

Interventions

DRUG

docetaxel

70 mg/sq m IV infusion over 1 hour Day 2 of ea cycle

DRUG

estramustine phosphate sodium

280 mg PO tid Days 1-5 of ea cycle

DRUG

exisulind

Two 125 mg capsules PO bid Days 1-21 of ea cycle

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Nancy Dawson, MD · University of Maryland Greenbaum Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2006-01-31
Completion
2009-04-30

Countries

  • United States
  • Canada
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00052845 on ClinicalTrials.gov