Irinotecan With or Without Oxaliplatin 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
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the colon or rectum Metastatic or recurrent disease that is not amenable to potentially curative treatment Progressive or recurrent disease during or after 1, and only 1, regimen of fluorouracil with or without leucovorin calcium or during or within 6 months after adjuvant chemotherapy with fluorouracil and leucovorin calcium PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT 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 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina No New York Heart Association class III or IV congestive heart failure No serious cardiac arrhythmia No history of cardiac toxicity from fluorouracil/leucovorin calcium No myocardial infarction within past 6 months Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: No uncontrolled predisposing colonic or small bowel disorder No prior chronic enteropathy, chronic diarrhea, or unresolved bowel obstruction/subobstruction No diabetes No active infection No known current peripheral neuropathy No concurrent active cancer except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No intolerance of appropriate antiemetics No history of anaphylaxis or potential intolerance to atropine sulfate or loperamide Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy No prior irinotecan or oxaliplatin No other prior chemotherapy agents except fluorouracil with or without leucovorin calcium as first-line therapy for metastatic disease or in the adjuvant setting Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy to non-target lesions allowed No prior radiotherapy to target lesions unless disease progression is documented within the radiation port At least 3 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgical procedure and recovered Prior surgery for primary tumor or metastasis allowed Other: At least 30 days since prior investigational drug No concurrent investigational agents
Sites / Locations
- Comprehensive Cancer Institute of Huntsville
- Oncology Center at Providence Park
- Arizona Clinical Research Center
- Citrus Valley Medical Center
- California Cancer Care, Inc.
- Tower Hematology Oncology Medical Group
- Kenmar Research 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
- John Wayne Cancer Institute
- Kaiser Permanente Medical Center - Vallejo
- Colorado Permanente Medical Group, P.C.
- Rocky Mountain Cancer Center
- University of Colorado Cancer Center
- Whittingham Cancer Center
- George Washington University Medical Center
- Comprehensive Cancer Care Specialists of Boca Raton
- Center for Hematology-Oncology
- Southeast Florida Hematology-Oncology Group
- Florida Cancer Specialists
- Shands Hospital and Clinics, University of Florida
- Hematology and Oncology Associates of Jacksonville
- University of Florida Health Science Center - Jacksonville
- Lakeland Regional Medical Center
- Lake Heart and Cancer Medical Center
- Oncology-Hematology Group of South Florida
- Hematology and Oncology Consultants, P.A.
- Hematology/Oncology Associates
- Oncology & Hematology Associates of West Broward
- University Community Hospital
- Hematology and Oncology Consultants
- North Idaho Cancer Center
- Northwest Medical Specialists, P.C.
- Dreyer Medical Clinic
- Northwestern Medical Faculty Foundation
- Cancer Care Center
- Albert B. Chandler Medical Center, University of Kentucky
- James Graham Brown Cancer Center
- Kentuckiana Cancer Institute
- Norton Healthcare Pavilion
- Veterans Affairs Medical Center - Louisville
- Baton Rouge General Medical Center
- Louisiana Oncology Associates
- Doctors Hospital of Jefferson
- Stanley Scott Cancer Center
- Greater Baltimore Medical Center and Cancer Center
- Medical Center of Boston
- Berkshire Hematology Oncology, P.C.
- Barbara Ann Karmanos Cancer Institute
- Parker Hughes Cancer Center
- Jackson Oncology Associates, PLLC
- Veterans Affairs Medical Center - Kansas City
- Siteman Cancer Center
- St. John's Mercy Medical Center
- Missouri Cancer Care, P.C.
- Great Falls Clinic
- Western Montana Clinic
- Somerset Medical Center
- Cooper Cancer Institute
- Veterans Affairs Medical Center - Albany
- Montefiore Medical Center
- Queens Medical Associates, PC
- Queens Hospital Center
- Interlakes Oncology/Hematology PC
- New York Medical College
- Lineberger Comprehensive Cancer Center, UNC
- Raleigh Hematology/Oncology Associates - Wake Practice
- Piedmont Hematology-Oncology Associates
- Cleveland Clinic Taussig Cancer Center
- Hematology Oncology Consultants Inc
- Bend Memorial Clinic
- Kaiser Permanente - Portland
- Pinnacle Health Hospitals
- Abington Hematology Oncology Associates, Incorporated
- University of Pennsylvania Cancer Center
- Pennsylvania Oncology Hematology Associates
- University of Pittsburgh Cancer Institute
- Lifespan: The Miriam Hospital
- Physicians East - Quadrangle
- Cancer Centers of the Carolinas
- Erlanger Health Systems
- Baptist Regional Cancer Center - Knoxville
- West Clinic
- Memphis Cancer Center
- Tennessee Oncology, P.L.L.C.
- Vanderbilt-Ingram Cancer Center
- Lone Star Oncology
- Center for Oncology Research and Treatment, Medical City Hospital
- Baptist Health System Cancer Program
- Huntsman Cancer Institute
- Cancer Center at the University of Virginia
- Hematology-Oncology Associates of Frederiksburg, Inc.
- Virginia Mason Medical Center
- Advanced Health Care
- UW Cancer Center Wausau Hospital
- Irving Cancer Center
- Porto Alegre Hospital
- Instituto de Oncologia de Soracaba
- Hospital Joao Alves Fiho
- Hospital Socor
- Hospital Erastos Gaertner
- Instituto Nacional de Cancer
- Oncologistas Associados
- Hospital do Cancer A C Comargo
- Tom Baker Cancer Center - Calgary
- University of Alberta
- Nova Scotia Cancer Centre
- Royal Victoria Hospital, Barrie
- Cancer Care Ontario-London Regional Cancer Centre
- Ottawa Regional Cancer Centre
- Northeastern Ontario Regional Cancer Centre, Sudbury
- Toronto Sunnybrook Regional Cancer Centre
- Mount Sinai Hospital - Toronto
- Princess Margaret Hospital
- Hopital Charles Lemoyne
- Cite de la Sante de Laval
- L'Hotel Dieu de Levis
- Maisonneuve-Rosemont Hospital
- Jewish General Hospital - Montreal
- Hopital Du Sacre-Coeur de Montreal
- Centre Hospitalier Universitaire de Quebec
- Centre Hospitalier de L'Universitaire de Quebec, Pavillon CHUL
- L'Hopital Laval
- Saskatoon Cancer Centre
- Zoom International Incoporated
- Centre of Clinical Oncology and Radiation Oncology
- Charles University Hospital
- Onkologicka Klinka A Onkologicka Lab
- Fakultni Nemocnice V Motole
- Semmelweis University
- National Institute of Oncology
- Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia
- Szent Laszlo Korhaz
- Kozponti Honvedkorhaz I. Belgyogyaszat
- Debreceni Egyetem Onkologiai Tanzek
- Petz Aladar County Hospital
- Maria S. Curie Memorial Institute
- Jagiellonian University
- Institute of Oncology
- Wielkopolskie Centrum Onkologii Oddzial Chemioterapii
- St. Luke's Cancer Center
- St. Bartholomew's Hospital
- Guy's and St. Thomas' Hospitals NHS Trust
- Charing Cross Hospital
- Maidstone Hospital
- Christie Hospital N.H.S. Trust
- Derriford Hospital
- Weston Park Hospital
- Royal Marsden Hospital
- Aberdeen Royal Infirmary