NCT00003232

Combination Chemotherapy in Treating Pain in Hormone Refractory Metastatic Prostate Cancer

Randomized Placebo-Controlled Trial of Mitoxantrone/Prednisone and Clodronate Versus Mitoxantrone/Prednisone Alone in Patients With Hormone Refractory Metastatic Prostate Cancer and Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: Male
• Age: 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: I. Compare the effect of mitoxantrone and prednisone with or without clodronate on localized bone pain in patients with hormone refractory metastatic prostate cancer. II. Compare the overall survival and quality of life of these patients after these treatments. OUTLINE: This is a randomized, double blinded, placebo controlled, multicenter study. Patients are stratified according to quality of pain (mild vs moderate) and previous corticosteroids or one regimen of non-anthracycline-containing cytotoxic chemotherapy (e.g., estramustine) vs none. Patients are assigned to 1 of 2 treatment arms. Arm I consists of oral prednisone twice a day and intravenous mitoxantrone followed by intravenous clodronate administered over 3 hours every 3 weeks. Arm II consists of oral prednisone twice a day and intravenous mitoxantrone followed by intravenous placebo administered over 3 hours every 3 weeks. Doses are adjusted for myelosuppression. Treatment continues until disease progression (although patients initially on placebo can continue on open-label clodronate) or until the maximum cumulative dose of mitoxantrone is reached. Patients with a palliative response may continue on prednisone and the study drug (clodronate or placebo) until disease progression. Quality of life is assessed before and every 3 weeks during study treatment. A daily pain diary is also maintained. All patients are followed at 2 weeks and then every 3 months until death. PROJECTED ACCRUAL: This study will accrue 204 patients.

Conditions

• Pain
• Prostate Cancer
• Quality of Life

Interventions

Type	Name	Description
DRUG	clodronate disodium
DRUG	mitoxantrone hydrochloride
DRUG	prednisone
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 1997-11-24
• Primary completion: 2002-05-01
• Completion: 2009-02-10
• First posted: 2004-04-09
• Last updated: 2020-04-03

Locations

21 sites across 1 country: Canada