Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent 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 adenocarcinoma of the colon or rectum Metastatic/recurrent disease not amenable to potentially curative therapy (e.g., inoperable metastatic disease) Documented sequential disease progression (by CT scan or MRI) after 2 prior chemotherapy regimens for metastatic/recurrent disease At least 1 unidimensionally measurable lesion At least 20 mm by conventional CT scan or MRI OR At least 10 mm by spiral CT scan Must have received prior fluorouracil (or capecitabine) and leucovorin calcium with or without irinotecan as first-line therapy and irinotecan with or without fluorouracil (or capecitabine) and leucovorin calcium as second-line therapy 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) SGOT and SGPT no greater than 2 times ULN (6 times ULN if documented liver metastases present) Alkaline phosphatase no greater than 2 times ULN (6 times ULN if documented liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV symptomatic congestive heart failure No serious cardiac arrhythmia No unstable angina No myocardial infarction within the past 6 months Pulmonary: No interstitial pneumonia No 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 peripheral neuropathy (absence of deep tendon reflexes as the sole neurologic abnormality allowed) No diabetes or active infection No known dihydropyrimidine dehydrogenase deficiency PRIOR CONCURRENT THERAPY: Biologic therapy: No prior anticancer biologic therapy Chemotherapy: See Disease Characteristics No prior oxaliplatin No prior adjuvant irinotecan Prior adjuvant fluorouracil and leucovorin calcium allowed At least 3 weeks since prior chemotherapy (e.g., second-line irinotecan with or without fluorouracil (or capecitabine) and leucovorin calcium) for metastatic disease and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy No prior radiotherapy to target lesion unless documented progression within the radiation portal Surgery: See Disease Characteristics At least 4 weeks since prior surgery for primary tumor or metastases and recovered Other: No prior investigational anticancer drug No other concurrent investigational agents
Sites / Locations
- Arizona Clinical Research Center
- Arkansas Cancer Clinic, P.A.
- Citrus Valley Medical Center
- Cancer Center and Beckman Research Institute, City of Hope
- California Cancer Care, Inc.
- Cedars-Sinai Medical Center
- Kenmar Research Institute
- Comprehensive Cancer Centers of the Desert
- Kaiser Permanente-Southern California Permanente Medical Group
- Kaiser Permanente Medical Center - Vallejo
- John Muir Medical Center
- Rocky Mountain Cancer Center
- Northwestern Connecticut Oncology-Hematology Associates
- Lombardi Cancer Center
- Center for Hematology-Oncology
- Halifax Medical Center
- Florida Cancer Specialists
- Hematology/Oncology Associates
- Lake Heart and Cancer Medical Center
- Oncology-Hematology Group of South Florida
- Florida Hospital Cancer Institute
- Hematology/Oncology Associates
- Northwest Medical Specialists, P.C.
- Dreyer Medical Clinic
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
- Cancer Care Specialists of Central Illinois, S.C.
- Hope Center
- Medical Oncology and Hematology Associates
- Mercy Cancer Center
- Lucille Parker Markey Cancer Center, University of Kentucky
- James Graham Brown Cancer Center
- Baton Rouge General Medical Center
- Cancer and Blood Institute
- Saints Memorial Medical Center
- Saint Joseph Mercy Hospital
- Medical Oncology Group
- Jackson Oncology Associates, PLLC
- St. Joseph Oncology, Inc.
- Deaconess Billings Clinic
- Monmouth Medical Center
- Jersey Shore Cancer Center
- Central Jersey Oncology Center
- Hematology Associates of New Jersey, P.A.
- Monmouth Hematology-Oncology Associates, P.A.
- University of New Mexico Cancer Research & Treatment Center
- Albert Einstein Comprehensive Cancer Center
- HemOnCare, P.C.
- North Shore Hematology/Oncology Associates, P.C.
- Reddy Cancer Treatment Center
- New York University Medical Center
- Memorial Sloan-Kettering Cancer Center
- Interlakes Oncology/Hematology PC
- University of Rochester Medical Center
- South Shore Hematology Oncology Associates, P.C.
- New York Medical College
- Mid-Ohio Oncology/Hematology, Inc.
- Hematology Oncology Consultants Inc
- Lawrence M. Stallings Medical Practice
- Oklahoma Oncology Inc.
- Bend Memorial Clinic
- Salem Hospital Regional Cancer Center
- Oncology Hematology of Lehigh Valley, P.C.
- Pennsylvania Oncology Hematology Associates
- Lifespan: The Miriam Hospital
- Memorial Hospital Cancer Center - Chattanooga
- Family Cancer Center
- Baptist Regional Cancer Center
- West Cancer Clinic
- Center for Oncology Research and Treatment, Medical City Hospital
- Cancer Therapy and Research Center
- Scott and White Memorial Hospital
- Huntsman Cancer Institute
- Intermountain Hematology/Oncology Associates, Inc.
- Seattle Cancer Care Alliance