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Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer Clinical research trials and Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer. Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer clinical trial. Human subjects often get the best healthcare available for their Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer  Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer
Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer
For Condition: recurrent colon cancer,Stage 4 rectal cancer,recurrent rectal cancer,stage 4 colon cancer,Quality of Life
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada , Australasian Gastro-Intestinal Trials Group
Synopsis: RATIONALE: Monoclonal antibodies, such as cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bestsupportive care is the use of drugs and other treatments to improve the quality of life of patients. Combining cetuximab with best supportive care may slow the growth of the tumor and help patients live longer and more comfortably. It is not yet known whether cetuximab combined with best supportive care is more effective than best supportive care alone in treating metastaticepidermal growth factor receptor-positive colorectal cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of cetuximab combined with best supportive care with that of best supportive care alone in treating patients who have metastatic epidermal growth factor receptor-positive colorectal cancer.
Details: OBJECTIVES: Primary - Compare survival of patients with metastatic epidermal growth factor receptor-positive colorectal cancer treated with cetuximab and best supportive care vs best supportive care alone. Secondary - Compare the time to disease progression in patients treated with these regimens. - Compare the objective response rate in patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. - Compare the health utilities of patients treated with these regimens. - Conduct a comparative economic evaluation in patients treated with these regimens. - Determine the safety profile of cetuximab in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive best supportive care, defined as measures designed to provide palliation of symptoms and improve quality of life as much as possible. - Arm II: Patients receive best supportive care as in arm I. Patients also receive an initial loading dose of cetuximab IV over 120 minutes on day 1. Patients continue to receive maintenance infusions of cetuximab IV over 60 minutes weekly. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, and then at 4, 8, 16, and 24 weeks (or until deterioration to ECOG PS 4 or hospitalization for end-of-life care). Patients are followed every 4 weeks. PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed colorectal cancer - Metastatic disease - Epidermal growth factor receptor (EGFR)-positive by immunochemistry - Measurable or evaluable disease - Not amenable to standard curative therapy - Best supportive care is the only available option - Must have received a prior thymidylate synthase inhibitor (e.g., 5-fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) in the adjuvant or metastatic setting - Combination therapy with oxaliplatin or irinotecan allowed - Must have failed* a prior regimen containing irinotecan or oxaliplatin for metastatic disease OR relapsed within 6 months after an adjuvant regimen containing irinotecan or oxaliplatin OR have documented unsuitability for such regimens - No symptomatic CNS metastases NOTE: *Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen PATIENT CHARACTERISTICS: Age - 16 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - See Disease Characteristics - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 75,000/mm^3 - Hemoglobin at least 8.0 g/dL Hepatic - AST/ALT no greater than 2.5 times upper limit of normal (ULN) - Bilirubin no greater than 1.5 times ULN Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No uncontrolled angina - No arrhythmias - No cardiomyopathy - No congestive heart failure - No myocardial infarction* within the past 6 months NOTE: *Pre-treatment ECG as only evidence of infarction is allowed Pulmonary - No severe restrictive lung disease - No interstitial lung disease by chest x-ray Other - No pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study treatment - No active pathological condition that would preclude study participation - No psychological or geographical condition that would preclude study compliance - No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - No prior cetuximab - No prior murine monoclonal antibody therapy (e.g., edrecolomab) Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy and recovered - No concurrent chemotherapy Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - Concurrent palliative radiotherapy allowed except to index lesions Surgery - At least 4 weeks since prior major surgery and recovered Other - No prior EGFR-targeted therapy (e.g., erlotinib or gefitinib) - More than 30 days since prior experimental therapeutic agents - More than 4 weeks since prior investigational agents - No concurrent enrollment in another clinical study - No other concurrent EGFR-targeted therapy - No other concurrent non-cytotoxic experimental agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DerekJonker, Study Chair, Ottawa Regional Cancer Centre
Mount Sinai Hospital - Toronto *Recruiting*
Toronto, Ontario, M5G 1X5
Canada
Recruiting Ronald Burkes 416-586-5117
Toronto East General Hospital *Recruiting*
Toronto, Ontario, M4C 3E7
Canada
Recruiting Jacinta Meharchand 416-469-3325
NHMRC Clinical Trials Centre *Recruiting*
Camperdown, New South Wales, 1450
Australia
Recruiting Chris Karapetis 61-8-8204-5511
Hotel Dieu Health Sciences Hospital - Niagara *Recruiting*
St. Catharines, Ontario, L2R 5K3
Canada
Recruiting Brian Findlay 905-682-6451
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Scott Berry 416-480-5248
Centre Hospitalier de l'Universite de Montreal *Recruiting*
Montreal, Quebec, H2L 4MI
Canada
Recruiting Danielle Charpentier 514-890-8200
Hopital Charles Lemoyne *Recruiting*
Greenfield Park, Quebec, J4V 2H1
Canada
Recruiting Marc Trudeau 450-466-5053
Hopital Du Sacre-Coeur de Montreal *Recruiting*
Montreal, Quebec, H4J 1C5
Canada
Recruiting Renaud Whittom 514-338-2050
Belleville General Hospital *Recruiting*
Belleville, Ontario, K8N 5K5
Canada
Recruiting Roger Levesque 613-962-6944
Kingston Regional Cancer Centre *Recruiting*
Kingston, Ontario, K7L 5P9
Canada
Recruiting Anna Tomiak 613-544-2630 ext. 4503
Northwestern Ontario Regional Cancer Care *Recruiting*
Thunder Bay, Ontario, P7B 6V4
Canada
Recruiting Dorie-Anna Dueck 807-343-1610
Ottawa Regional Cancer Centre *Recruiting*
Ottawa, Ontario, K1H 1C4
Canada
Recruiting Derek Jonker 613-737-7700
Moncton Hospital *Recruiting*
Moncton, New Brunswick, E1C 6ZB
Canada
Recruiting Sheldon Rubin 506-857-2881
Allan Blair Cancer Centre *Recruiting*
Regina, Saskatchewan, S4T 7T1
Canada
Recruiting Haji Chalchal 306-766-2691
Durham Regional Cancer Centre at Lakeridge Health Oshawa *Recruiting*
Oshawa, Ontario, L1G 2B9
Canada
Recruiting Rafal Wierzbicki 905-576-8711 ext. 4044
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Malcolm Moore 416-946-2263
Grand River Regional Cancer Centre *Recruiting*
Kitchner, Ontario, N2G 1G3
Canada
Recruiting Gregory Knight 519-749-4370
Cross Cancer Institute *Recruiting*
Edmonton, Alberta, T6G 1Z2
Canada
Recruiting Sheryl Koski 780-432-8221
Cancer Care Ontario - Windsor Regional Cancer Centre *Recruiting*
Windsor, Ontario, N8W 2X3
Canada
Recruiting John Matthews 519-253-3191 ext. 58504
Additional Information:
Study ID Numbers: CDR0000353486; BMS-CA225-025,CAN-NCIC-CO17,IMCL-CAN-NCIC-CO17,AGITG-CAN-NCIC-CO17
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079066
Other Stage 4 Colon Cancer Studies:
1. Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
2. Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer
3. Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
4. Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
5. Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
Related Studies:
Other stage 4 colon cancer Clinical Trials
Other Ontario Clinical Trials
Other Toronto Clinical Trials
Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer
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