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Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer Clinical research trials and Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer. Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer  Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer
Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer
For Condition: Pain,adenocarcinoma of the prostate,recurrent prostate cancer,Quality of Life
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
D.Ernst, Study Chair, National Cancer Institute of Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
B.C. Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Canada
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6
Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
Penticton Regional Hospital
Penticton, British Columbia, V2A 3G6
Canada
Ottawa Regional Cancer Center - General Division
Ottawa, Ontario, K1H 8L6
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, C1A 8T5
Canada
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6
Canada
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Canada
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Canada
Hotel Dieu Hospital - St. Catharines
St. Catharines, Ontario, L2R 5K3
Canada
Additional Information:
Study ID Numbers: CDR0000066102; CAN-NCIC-PR6
Study Start Date: November 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003232
Other Quality Of Life Studies:
1. PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
2. Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
3. Effectiveness of Telephone Counseling By Breast Cancer Survivors on the Well-Being of Women With Recurrent Breast Cancer
4. Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy
5. Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
Related Studies:
Other Quality of Life Clinical Trials
Other Newfoundland and Labrador Clinical Trials
Other St. Johns Clinical Trials
Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer
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