Combination Chemotherapy in Treating Pain in Hormone Refractory Metastatic Prostate Cancer
- Conditions
- PainProstate CancerQuality of Life
- Registration Number
- NCT00003232
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 227
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Cancer Care Ontario - Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Penticton Regional Hospital
🇨🇦Penticton, British Columbia, Canada
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
Peterborough Oncology Clinic
🇨🇦Peterborough, Ontario, Canada
Trillium Health Centre
🇨🇦Mississauga, Ontario, Canada
Ottawa Regional Cancer Center - General Division
🇨🇦Ottawa, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Hotel Dieu Hospital - St. Catharines
🇨🇦St. Catharines, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
🇨🇦Thunder Bay, Ontario, Canada
Humber River Regional Hospital
🇨🇦Weston, Ontario, Canada
Queen Elizabeth Hospital, PEI
🇨🇦Charlottetown, Prince Edward Island, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
Newfoundland Cancer Treatment and Research Foundation
🇨🇦St. Johns, Newfoundland and Labrador, Canada
McGill University Department of Oncology
🇨🇦Montreal, Quebec, Canada
B.C. Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada