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Sponsored by: |
NCIC Clinical Trials Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003232 |
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.
Condition | Intervention | Phase |
---|---|---|
Pain Prostate Cancer Quality of Life |
Drug: clodronate disodium Drug: mitoxantrone hydrochloride Drug: prednisone Procedure: quality-of-life assessment |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Randomized Placebo-Controlled Trial of Mitoxantrone/Prednisone and Clodronate Versus Mitoxantrone/Prednisone Alone in Patients With Hormone Refractory Metastatic Prostate Cancer and Pain |
Estimated Enrollment: | 204 |
Study Start Date: | November 1997 |
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate or metastatic carcinoma of presumptive prostate origin as manifest by the presence of sclerotic bony metastases and a serum PSA level greater than the upper limit of normal Radiologically proven progressive bone disease (e.g., new bone scan lesions, increased uptake of isotope at previous sites of disease, and/or increasing bone pain) Hormone refractory disease (i.e., disease progression or recurrence despite documented castrate levels of serum testosterone achieved by bilateral orchiectomy or antiandrogen therapy) Bone pain due to metastatic disease Patients must have achieved stable analgesia for at least 7 days No uncontrolled epidural metastases
PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-3 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 3.15 mg/dL Renal: Creatinine less than 2.26 mg/dL Serum calcium no greater than 3.1 mmol/L Cardiovascular: Patients with history of angina pectoris, previous cardiac infarction, hypertension, or valvular or congenital heart disease must have baseline measurement of LVEF exceeding 50% Other: No other malignancy within 5 years except nonmelanomatous skin cancer No active infection or any other contraindication to chemotherapy with mitoxantrone No spinal cord or nerve root compression No unstabilized impending pathological fractures
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: One previous course of chemotherapy allowed No prior mitoxantrone or other anthracycline Endocrine therapy: See Disease Characteristics At least 4 weeks since prior nonsteroidal antiandrogens Radiotherapy: At least 4 weeks since prior radiotherapy At least 8 weeks since prior strontium-89 or samarium-153 Surgery: Not specified Other: No prior bisphosphonate therapy
Canada, Alberta | |
Tom Baker Cancer Center - Calgary | |
Calgary, Alberta, Canada, T2N 4N2 | |
Canada, British Columbia | |
B.C. Cancer Agency | |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
British Columbia Cancer Agency - Fraser Valley Cancer Centre | |
Surrey, British Columbia, Canada, V3V 1Z2 | |
Penticton Regional Hospital | |
Penticton, British Columbia, Canada, V2A 3G6 | |
Canada, New Brunswick | |
Saint John Regional Hospital | |
Saint John, New Brunswick, Canada, E2L 4L2 | |
Canada, Newfoundland and Labrador | |
Newfoundland Cancer Treatment and Research Foundation | |
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6 | |
Canada, Nova Scotia | |
Nova Scotia Cancer Centre | |
Halifax, Nova Scotia, Canada, B3H 1V7 | |
Canada, Ontario | |
Cancer Care Ontario - Windsor Regional Cancer Centre | |
Windsor, Ontario, Canada, N8W 2X3 | |
Cancer Care Ontario-Hamilton Regional Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Cancer Care Ontario-London Regional Cancer Centre | |
London, Ontario, Canada, N6A 4L6 | |
Hotel Dieu Hospital - St. Catharines | |
St. Catharines, Ontario, Canada, L2R 5K3 | |
Humber River Regional Hospital | |
Weston, Ontario, Canada, M9N 1N8 | |
Kingston Regional Cancer Centre | |
Kingston, Ontario, Canada, K7L 5P9 | |
Northwestern Ontario Regional Cancer Centre, Thunder Bay | |
Thunder Bay, Ontario, Canada, P7A 7T1 | |
Ottawa Regional Cancer Center - General Division | |
Ottawa, Ontario, Canada, K1H 8L6 | |
Peterborough Oncology Clinic | |
Peterborough, Ontario, Canada, K9H 7B6 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Toronto Sunnybrook Regional Cancer Centre | |
Toronto, Ontario, Canada, M4N 3M5 | |
Trillium Health Centre | |
Mississauga, Ontario, Canada, L5B 1B8 | |
Canada, Prince Edward Island | |
Queen Elizabeth Hospital, PEI | |
Charlottetown, Prince Edward Island, Canada, C1A 8T5 | |
Canada, Quebec | |
McGill University Department of Oncology | |
Montreal, Quebec, Canada, H2W 1S6 |
Study Chair: | Donald S. Ernst, MD, FRCPC | Tom Baker Cancer Centre - Calgary |
Study ID Numbers: | CDR0000066102, CAN-NCIC-PR6 |
Study First Received: | November 1, 1999 |
Last Updated: | May 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00003232 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate recurrent prostate cancer pain quality of life |
Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Quality of Life Bone Density Conservation Agents Pain Urogenital Neoplasms |
Genital Diseases, Male Glucocorticoids Hormones Recurrence Clodronic Acid Peripheral Nervous System Agents Analgesics Mitoxantrone Adenocarcinoma Prostatic Neoplasms |
Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Bone Density Conservation Agents Genital Diseases, Male Hormones |
Glucocorticoids Pharmacologic Actions Clodronic Acid Neoplasms Neoplasms by Site Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Analgesics Mitoxantrone Central Nervous System Agents Prostatic Neoplasms |