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Combination Chemotherapy in Treating Pain in Hormone Refractory Metastatic Prostate Cancer

NCT00003232 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2020-04-03

No results posted yet for this study

Summary

RATIONALE: Some drugs used in chemotherapy can reduce the pain experienced by some people with cancer. Combining more than one drug may be more effective at reducing cancer pain. It is not known whether receiving combination chemotherapy with clodronate is more effective than receiving combination chemotherapy without clodronate for hormone refractory metastatic prostate cancer.

PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of combination chemotherapy using mitoxantrone plus prednisone with or without clodronate in treating pain in patients with hormone refractory metastatic prostate cancer.

Conditions

Interventions

DRUG

clodronate disodium

DRUG

mitoxantrone hydrochloride

DRUG

prednisone

PROCEDURE

quality-of-life assessment

Sponsors & Collaborators

  • NCIC Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Donald S. Ernst, MD, FRCPC · Tom Baker Cancer Centre - Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-11-24
Primary Completion
2002-05-01
Completion
2009-02-10

Countries

  • Canada

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 NCT00003232 on ClinicalTrials.gov