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Chemotherapy With or Without Biological Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

NCT00005847 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-06-22

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known which treatment regimen is more effective in treating metastatic prostate cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy with that of chemotherapy plus biological therapy in treating patients who have progressive or metastatic prostate cancer that has not responded to hormone therapy.

Conditions

Interventions

BIOLOGICAL

recombinant interferon alfa

DRUG

estramustine phosphate sodium

DRUG

isotretinoin

DRUG

mitoxantrone hydrochloride

DRUG

paclitaxel

DRUG

vinorelbine ditartrate

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Robert S. DiPaola, MD · Rutgers Cancer Institute of New Jersey

  • Robert G. Kilbourn, MD, PhD · Texas Oncology, PA - San Marcos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

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

Timeline & Regulatory

Start
2001-04-05
Primary Completion
2004-07-31

Countries

  • United States

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 NCT00005847 on ClinicalTrials.gov