Comparison of Three Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum that is not amenable to potentially curative therapy (e.g., inoperable metastatic disease) At least 1 unidimensionally measurable lesion at least 20 mm in diameter by conventional CT or MRI scan or at least 10 mm in diameter by spiral CT scan Progressive disease by CT or MRI scan during or no more than 6 months after the last dose of prior first-line irinotecan, fluorouracil, and leucovorin calcium (Saltz regimen) for metastatic disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 3 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No uncontrolled high blood pressure No unstable angina, symptomatic congestive heart failure, or serious cardiac arrhythmia No New York Heart Association class III or IV heart disease No history of cardiac toxicities with prior fluorouracil and leucovorin calcium No myocardial infarction within the past 6 months Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No known dihydropyrimidine dehydrogenase deficiency No allergy to platinum-containing drugs No history of intolerance to study anti-emetics (e.g., 5-HT3 antagonists) No known peripheral neuropathy (absence of deep tendon reflexes as sole deficiency allowed) No uncontrolled diabetes No active infection No other active malignancy originating from primary site other than colon or rectum PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics One and only 1 prior chemotherapy regimen for metastatic disease consisting of first-line irinotecan, fluorouracil, and leucovorin calcium (Saltz regimen) Prior adjuvant fluorouracil with leucovorin calcium allowed At least 3 weeks since prior chemotherapy for metastatic disease and recovered No prior adjuvant irinotecan No prior oxaliplatin Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to study lesions unless evidence of progressive disease within the radiotherapy port At least 3 weeks since prior radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery and recovered Prior surgical resection of primary tumor or metastases allowed Other: At least 30 days since prior investigational drugs No other concurrent investigational agents No other concurrent anti-cancer therapy No concurrent participation in other investigational trials
Sites / Locations
- Comprehensive Cancer Institute of Huntsville
- Oncology Center at Providence Park
- Arizona Clinical Research Center
- Arkansas Oncology Associates, P.A.
- Offices of Richard Shapiro, Benjamin Stafford, and Sharon J. Yee
- California Cancer Care, Inc.
- Medical Oncology Internal Medicine
- Bay Area Tumor Institute
- Medical Oncology Care Associates
- P.M.K. Medical Group, Inc.
- Cancer and Blood Institute of the Desert
- Kaiser Permanente-Southern California Permanente Medical Group
- Kaiser Permanente Medical Center - Vallejo
- Kaiser Permanente - Denver
- Rocky Mountain Cancer Center
- Northwestern Connecticut Oncology-Hematology Associates
- Lombardi Cancer Center
- Comprehensive Cancer Care Specialists of Boca Raton
- Center for Hematology-Oncology
- Florida Cancer Specialists
- University of Florida Health Science Center
- Memorial Regional Hospital Comprehensive Cancer Center
- Florida Community Cancer Center
- North Florida Hematology & Oncology Associates
- Hematology/Oncology Associates
- Lakeland Regional Medical Center
- Mount Sinai Comprehensive Cancer Center
- Oncology-Hematology Group of South Florida
- Ocala Oncology Center
- Office of Thomas A. Marsland
- Florida Hospital Cancer Institute
- Office of Barry S. Berman
- Memorial Hospital West
- Hematology-Oncology Associates, PA
- Hematology/Oncology Associates
- Oncology & Hematology Associates of West Broward
- Office of Ron D. Schiff
- Hematology and Oncology Consultants
- Dreyer Medical Clinic
- Northwestern Medical Faculty Foundation
- Hematology Oncology Associates of Illinois-Highland Park
- Lutheran General Cancer Care Center
- Oncology and Hematology Associates
- Cancer Care Center
- Oncology Associates of Cedar Rapids
- University of Kansas Medical Center
- Cancer Center of Kansas - Wichita
- Albert B. Chandler Medical Center, University of Kentucky
- James Graham Brown Cancer Center
- Baton Rouge General Medical Center
- Louisiana Oncology Associates
- Physicians Office
- Louisiana State University School of Medicine
- Maine Center for Cancer Medicine and Blood Disorders
- Barbara Ann Karmanos Cancer Institute
- Parker Hughes Cancer Center
- Park Nicollet Clinic
- Columbia Comprehensive Cancer Care Clinic
- Missouri Cancer Associates
- Midwest Oncology Consortium
- Missouri Baptist Cancer Center
- St. John's Mercy Medical Center
- Missouri Cancer Care, P.C.
- Cooper Hospital/University Medical Center
- Veterans Affairs Medical Center - Albany
- Albert Einstein Comprehensive Cancer Center
- Roswell Park Cancer Institute
- North Shore Hematology/Oncology Associates, P.C.
- Capitol District Hematology Oncology Associates, P.C.
- St. Vincents Comprehensive Cancer Center
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- Interlakes Oncology/Hematology PC
- State University of New York Health Sciences Center - Stony Brook
- New York Medical College
- Lineberger Comprehensive Cancer Center, UNC
- Regional Hematology Oncology Associates
- Raleigh Hematology/Oncology Associates - Wake Practice
- Piedmont Hematology-Oncology Associates-Triad
- Hematology Oncology Consultants Inc
- Dayton Oncology/Hematology P.A.
- Naz Medical Center
- Cancer Care Associates
- Willamette Valley Cancer Center
- Abington Memorial Hospital
- Oncology/Hematology Associates - Beaver
- University of Pennsylvania Cancer Center
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- Pennsylvania Oncology Hematology Associates
- University of Pittsburgh Cancer Institute
- Cancer Centers of the Carolinas
- Erlanger Health Systems
- Baptist Regional Cancer Center - Knoxville
- West Clinic, P.C.
- Memphis Cancer Center
- St. Thomas Medical Center
- Vanderbilt-Ingram Cancer Center
- Lone Star Oncology
- Texas Oncology P.A.
- Center for Oncology Research and Treatment, Medical City Hospital
- Simmons Cancer Center - Dallas
- Texas Cancer Center Southwest
- Texas Oncology PA (TOPA) at Baylor-Sammons
- Texas Oncology, P.A.
- Texas Oncology, P.A.
- South Texas Regional Cancer Centers - McAllen
- Texas Oncology - Mesquite
- Baptist Health System Cancer Program
- San Antonio Tumor and Blood Clinic
- Tyler Cancer Center
- Huntsman Cancer Institute
- Hematology-Oncology Associates of Frederiksburg, Inc.
- Virginia Oncology Associates - Newport News
- Hematology & Oncology Associates of Virginia
- Virginia Mason Medical Center
- Swedish Medical Center
- Cancer Care Northwest
- Northwest Cancer Specialists
- University of Wisconsin Comprehensive Cancer Center
- Advanced Health Care
- UW Cancer Center Wausau Hospital
- Ivinson Memorial Hospital
- Tom Baker Cancer Center - Calgary
- University of Alberta
- St. Boniface General Hospital
- Nova Scotia Cancer Centre
- Belleville General Hospital
- Cancer Care Ontario-London Regional Cancer Centre
- Peterborough Oncology Clinic
- Toronto Sunnybrook Regional Cancer Centre
- Mount Sinai Hospital - Toronto
- Princess Margaret Hospital
- Notre Dame Hospital
- Centre Hospitalier Regional de Rimouski
- Saskatoon Cancer Centre