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Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

NCT00030654 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-10-22

No results posted yet for this study

Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as luteinizing hormone-releasing hormone agonist, flutamide, and bicalutamide may stop the adrenal glands from producing androgens. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy given at the same time as hormone therapy is more effective than chemotherapy given after hormone therapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given at the same time as hormone therapy with that of chemotherapy given after hormone therapy in treating patients who have prostate cancer.

Conditions

Interventions

DRUG

bicalutamide

DRUG

docetaxel

DRUG

doxorubicin hydrochloride

DRUG

estramustine phosphate sodium

DRUG

flutamide

DRUG

ketoconazole

DRUG

paclitaxel

DRUG

releasing hormone agonist therapy

DRUG

vinblastine sulfate

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • SWOG Cancer Research Network

    collaborator NETWORK

  • NRG Oncology

    collaborator OTHER

  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • Kenneth J. Pienta, MD, FACP · University of Michigan Rogel Cancer Center

  • Naomi S. Balzer-Haas, MD · Fox Chase Cancer Center

  • Arif Hussain, MD · University of Maryland Greenebaum Cancer Center

  • Gregory P. Swanson, MD · Deaconess Medical Center, Spokane, Washington

  • Primo N. Lara, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2005-02-04
Completion
2005-02-04

Countries

  • United States
  • Australia
  • Peru
  • 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 NCT00030654 on ClinicalTrials.gov