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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy Compared With No Further Therapy After Surgery in Treating Patients With Stage II Colon Cancer  Monoclonal Antibody Therapy Compared With No Further Therapy After Surgery in Treating Patients With Stage II Colon Cancer
Monoclonal Antibody Therapy Compared With No Further Therapy After Surgery in Treating Patients With Stage II Colon Cancer
For Condition: adenocarcinoma of the colon,stage 2 colon cancer
Status: No longer recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI),Southwest Oncology Group,Eastern Cooperative Oncology Group,North Central Cancer Treatment Group,EORTC Gastrointestinal Tract Cancer Cooperative Group,National Cancer Institute of Canada
Synopsis: RATIONALE: Monoclonal antibodies such as edrecolomab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether surgery to remove colon cancer is more effect with or without monoclonal antibody therapy. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without monoclonal antibody therapy in treating patients who have stage II colon cancer.
Details: OBJECTIVES: - Determine whether adjuvant therapy with edrecolomab improves the probability of survival and disease-free survival and increases disease-free intervals in patients who have undergone resection for stage II colon cancer. - Determine whether alterations in the expression cell cycle related genes predict the risk of survival or recurrence in this patient population. - Determine whether alterations in markers of metastatic potential such as expression of the "Deleted in Colon Cancer" (DCC) gene, and measures of tumor angiogenesis predict the risk of survival and recurrence in these patients. - Determine whether markers of cellular differentiation (e.g., sucrase isomaltase) predict the risk of survival or recurrence in these patients. - Determine whether DNA ploidy and cell proliferation are prognostic of tumor recurrence and overall survival in stage II colon cancer. - Determine whether interactions among these tumor markers identify subsets of patients with significantly altered outcomes. - Determine whether pathologic features including tumor grade, tumor mitotic (proliferation) index, tumor border configuration, and host lymphoid response to tumor and lymphatic, venous, and perineural invasion predict outcome in this patient population. OUTLINE: This is a randomized study. Patients are stratified according to degree of differentiation (well vs moderately well vs poor), vascular or lymphatic invasion (no vs yes), and preoperative serum CEA (less than 5.0 ng/mL vs at least 5.0 ng/mL vs unknown). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive adjuvant edrecolomab IV over 2 hours on day 1. Treatment repeats every 28 days for 5 courses. Patients must begin therapy no earlier than 7 days and no later than 42 days postsurgical resection. Patients also undergo observation at 3 and 6 months postrandomization. - Arm II: Patients undergo observation at 3 and 6 months postrandomization. Patients are followed after the last course of edrecolomab (arm I) and at 12 months (arm II). All patients are followed every 6 months for 5 years. PROJECTED ACCRUAL: A total of 2,100 patients will be accrued for this study within 4.7 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven adenocarcinoma of the colon (Stage II pT3, N0 or pT4b, N0, excluding pT4a, N0) - With or without penetration of the serosa - No lymph node metastases - No distant metastases or penetration of adjacent structures/organs - Proximal, distal, and radial margins must be tumor free - A minimum of three (optimal of 6) nodes (pericolic or mesenteric) are required for evaluation - Complete en bloc resection of all primary tumors (not performed or assisted by laparoscopic methods) - No evidence of perforation or obstruction of the bowel - Must be a colon, not a rectal, cancer - More than one synchronous primary colon tumor allowed PATIENT CHARACTERISTICS: Age: - 18 and over Performance Status: - CALGB 0-1 Life Expectancy: - More than 2 years Hematopoietic: - Granulocyte count greater than 1,800/mm3 - Platelet count greater than 100,000/mm3 Hepatic: - BUN less than 1.5 times normal - Bilirubin less than 1.5 times normal Renal: - Creatinine less than 1.5 times normal Cardiovascular: - No uncontrolled or severe cardiovascular disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No other prior or concurrent malignancies within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix - No psychosis - No history of pancreatitis PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior exposure to murine antibodies Chemotherapy: - No prior chemotherapy for adenocarcinoma of the colon - No concurrent chemotherapy Endocrine therapy: - No concurrent systemic steroids - No concurrent hormonal therapy except for non-disease-related conditions (e.g., insulin for diabetes) - No concurrent corticosteroids, including replacement steroids for adrenal insufficiency - Concurrent inhaled steroids in daily doses of 500 ug or less allowed - Concurrent topical steroids allowed Radiotherapy: - No prior radiotherapy for adenocarcinoma of the colon Surgery: - See Disease Characteristics - Recovered from prior surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasColacchio, Study Chair, Dartmouth-Hitchcock Medical Center
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
L'Hotel Dieu de Levis
Levis, Quebec, G6V 3Z1
Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3
Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Canada
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, G1R 2J6
Canada
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6
Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Canada
Nanaimo Cancer Clinic
Nanaimo, British Columbia, V9S 2B7
Canada
L'Hopital Laval
Ste Foy, Quebec, G1V 4G5
Canada
Algoma District Medical Group
Sault Sainte Marie, Ontario, P6B 1Y5
Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, P3E 5J1
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB
Canada
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, C1A 8T5
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
CHUM Hopital Saint-Luc
Montreal, Quebec, H2X 3J4
Canada
Complexe Hospitalier de la Sagamie
Chicoutimi, Quebec, G7H 5H6
Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Lions Gate Hospital
North Vancouver, , V7L 2P9
Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Canada
Scarborough Hospital - General Site
Scarborough, Ontario, M1P 2V5
Canada
Additional Information:
Study ID Numbers: CDR0000065473; CLB-9581,CAN-NCIC-CO14,E-C9581,EORTC-40991,NCCTG-C9581,SWOG-C9581
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002968
Other Adenocarcinoma Of The Colon Studies:
1. Combination Chemotherapy in Treating Patients With Colon Cancer
2. Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer
3. Monoclonal Antibody Therapy Compared With No Further Therapy After Surgery in Treating Patients With Stage II Colon Cancer
4. Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer
5. Lymph Node Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I, Stage II, or Stage III Colorectal Cancer
Related Studies:
Other adenocarcinoma of the colon Clinical Trials
Other New Brunswick Clinical Trials
Other Moncton Clinical Trials
Monoclonal Antibody Therapy Compared With No Further Therapy After Surgery in Treating Patients With Stage II Colon Cancer
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