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Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer Clinical research trials and Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer. Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer  Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
For Condition: Colon Cancer,Rectal Cancer
Status: No longer recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI),Southwest Oncology Group,Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with that of combination chemotherapy in treating patients who have advanced colorectal cancer that has not responded to previous treatment.
Details: OBJECTIVES: - Compare the overall survival of patients with locally advanced, locally recurrent, or metastatic colorectal cancer treated with oxaliplatin, fluorouracil, and leucovorin calcium versus irinotecan, after initial therapy with fluorouracil. - Determine the time to progression, time to treatment failure, and overall response rate in patients treated with these 2 regimens. - Determine the toxic effects of these 2 regimens in these patients. - Compare the quality of life of patients treated with these 2 regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (ECOG 0-1 vs 2), primary indicator lesion (hepatic vs pulmonary vs other), age (less than 65 vs at least 65 years), alkaline phosphatase (less than 2 vs at least 2 times ULN), fluorouracil failure (adjuvant vs metastatic), and membership (intergroup vs expanded participation project). Patients are randomized to one of two treatment arms: - Arm I: Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on days 1 and 2, and fluorouracil IV bolus followed by IV infusion over 22 hours on days 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience progression or toxicity on the initial regimen may crossover to the other regimen. At least 3 weeks must elapse between regimens. Quality of life is assessed at baseline, prior to each chemotherapy course, at crossover, and at the end of the study. Patients are followed every 6 months for 3 years or until death. PROJECTED ACCRUAL: A total of 560 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma not curable by surgery or radiotherapy - Progressive disease following: - One prior fluorouracil based chemotherapy regimen for metastatic disease OR - Failure during or within 6 months after fluorouracil based adjuvant therapy - Measurable or evaluable disease - No CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL (transfusion allowed) Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST no greater than 5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 5 times ULN Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No uncontrolled high blood pressure - No unstable angina - No symptomatic congestive heart failure - No myocardial infarction with the past 6 months - No serious uncontrolled cardiac arrhythmias - No New York Heart Association class III or IV heart disease Pulmonary: - No pleural effusion or ascites that cause respiratory compromise (e.g., dyspnea grade 2 or greater) - No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung Other: - Not pregnant or nursing - Fertile patients must use effective contraception - Fluent in English - No active or uncontrolled infection - No other prior malignancy within the past 5 years, except: - Adequately treated basal or squamous cell skin cancer - Adequately treated noninvasive carcinomas - No sensory neuropathy grade 2 or greater - No uncontrolled colonic or small bowel disorders (greater than 3 loose stools daily) PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent sargramostim (GM-CSF) Chemotherapy: - At least 4 weeks since prior chemotherapy and recovered - No more than 1 prior chemotherapy regimen for advanced colorectal cancer - No prior irinotecan or other camptothecin derivative (e.g., topotecan) - No prior oxaliplatin - No other concurrent investigational chemotherapy agents Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior major radiotherapy - No prior radiotherapy to greater than 25% of bone marrow Surgery: - At least 4 weeks since prior major surgery and recovered - At least 2 weeks since prior minor surgery and recovered
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HenryPitot, Study Chair, Mayo Clinic Cancer Center
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, 79106
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
United States
CCOP - Dayton
Dayton, Ohio, 45429
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
Altru Cancer Center
Grand Forks, North Dakota, 58201
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
Kansas Cancer Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07019
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80010
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Danville Radiation Therapy Center
Memphis, Tennessee, 38104
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267-0501
United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78229
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Loyola University Medical Center
Maywood, Illinois, 60153-5500
United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97201-3098
United States
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Puget Sound Oncology Consortium
Seattle, Washington, 98109
United States
Medcenter One Health System
Bismark, North Dakota, 58501-5505
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
Pretoria Academic Hospital
Pretoria, , 0001
South Africa
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Harrington Cancer Center
Amarillo, Texas, 79106
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4095
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, 02118
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York City, New York, 10032
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, 92868
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724
United States
Genesis Medical Center
Davenport, Iowa, 52804
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Additional Information:
Study ID Numbers: CDR0000067623; NCCTG-N9841,ECOG-N9841,SWOG-N9841
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005036
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3. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Colorectal Cancer
4. Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
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Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
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