Phase
Condition
Colorectal Cancer
Rectal Cancer
Colon Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Study Design
Study Description
Connect with a study center
Arizona Clinical Research Center
Tucson, Arizona 85712
United StatesSite Not Available
Arkansas Cancer Clinic, P.A.
Pine Bluff, Arkansas 71603
United StatesSite Not Available
Citrus Valley Medical Center
Covina, California 92807
United StatesSite Not Available
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California 91010-3000
United StatesSite Not Available
California Cancer Care, Inc.
Greenbrae, California 94904
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Kenmar Research Institute
Los Angeles, California 90057
United StatesSite Not Available
Comprehensive Cancer Centers of the Desert
Palm Springs, California 92262
United StatesSite Not Available
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California 92120
United StatesSite Not Available
Kaiser Permanente Medical Center - Vallejo
Vallejo, California 94589
United StatesSite Not Available
John Muir Medical Center
Walnut Creek, California 94598
United StatesSite Not Available
Rocky Mountain Cancer Center
Denver, Colorado 80218
United StatesSite Not Available
Northwestern Connecticut Oncology-Hematology Associates
Torrington, Connecticut 06790
United StatesSite Not Available
Lombardi Cancer Center
Washington, District of Columbia 20007
United StatesSite Not Available
Center for Hematology-Oncology
Boca Raton, Florida 33486
United StatesSite Not Available
Halifax Medical Center
Daytona Beach, Florida 32114
United StatesSite Not Available
Florida Cancer Specialists
Fort Myers, Florida 33901
United StatesSite Not Available
Hematology/Oncology Associates
Jacksonville, Florida 32216
United StatesSite Not Available
Lake Heart and Cancer Medical Center
Leesburg, Florida 34748
United StatesSite Not Available
Oncology-Hematology Group of South Florida
Miami, Florida 33176
United StatesSite Not Available
Florida Hospital Cancer Institute
Orlando, Florida 32804
United StatesSite Not Available
Hematology/Oncology Associates
Port Saint Lucie, Florida 34952
United StatesSite Not Available
Northwest Medical Specialists, P.C.
Arlington Heights, Illinois 60004
United StatesSite Not Available
Dreyer Medical Clinic
Aurora, Illinois 60506
United StatesSite Not Available
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois 60611-3013
United StatesSite Not Available
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois 62526
United StatesSite Not Available
Hope Center
Terre Haute, Indiana 47809
United StatesSite Not Available
Medical Oncology and Hematology Associates
Des Moines, Iowa 50309
United StatesSite Not Available
Mercy Cancer Center
Mason City, Iowa 50401
United StatesSite Not Available
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky 40536-0093
United StatesSite Not Available
James Graham Brown Cancer Center
Louisville, Kentucky 40202
United StatesSite Not Available
Baton Rouge General Medical Center
Baton Rouge, Louisiana 70821-2511
United StatesSite Not Available
Cancer and Blood Institute
Metairie, Louisiana 70006
United StatesSite Not Available
Saints Memorial Medical Center
Lowell, Massachusetts 01852
United StatesSite Not Available
Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
United StatesSite Not Available
Medical Oncology Group
Gulfport, Mississippi 39501
United StatesSite Not Available
Jackson Oncology Associates, PLLC
Jackson, Mississippi 39202
United StatesSite Not Available
St. Joseph Oncology, Inc.
Saint Joseph, Missouri 64506
United StatesSite Not Available
Deaconess Billings Clinic
Billings, Montana 59107-5100
United StatesSite Not Available
Monmouth Medical Center
Long Branch, New Jersey 07740-6395
United StatesSite Not Available
Jersey Shore Cancer Center
Neptune, New Jersey 07753
United StatesSite Not Available
Central Jersey Oncology Center
New Brunswick, New Jersey 08901
United StatesSite Not Available
Hematology Associates of New Jersey, P.A.
Ridgewood, New Jersey 07450
United StatesSite Not Available
Monmouth Hematology-Oncology Associates, P.A.
West Long Branch, New Jersey 07764
United StatesSite Not Available
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico 87131
United StatesSite Not Available
Albert Einstein Comprehensive Cancer Center
Bronx, New York 10461
United StatesSite Not Available
HemOnCare, P.C.
Brooklyn, New York 11235
United StatesSite Not Available
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York 11733
United StatesSite Not Available
Reddy Cancer Treatment Center
Malone, New York 12953
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10021
United StatesSite Not Available
New York University Medical Center
New York, New York 10016
United StatesSite Not Available
Interlakes Oncology/Hematology PC
Rochester, New York 14623
United StatesSite Not Available
University of Rochester Medical Center
Rochester, New York 14642
United StatesSite Not Available
South Shore Hematology Oncology Associates, P.C.
Rockville Centre, New York 11570
United StatesSite Not Available
New York Medical College
Valhalla, New York 10595
United StatesSite Not Available
Hematology Oncology Consultants Inc
Columbus, Ohio 43235
United StatesSite Not Available
Mid-Ohio Oncology/Hematology, Inc.
Columbus, Ohio 43213
United StatesSite Not Available
Lawrence M. Stallings Medical Practice
Wooster, Ohio 44691
United StatesSite Not Available
Oklahoma Oncology Inc.
Tulsa, Oklahoma 74104
United StatesSite Not Available
Bend Memorial Clinic
Bend, Oregon 97701
United StatesSite Not Available
Salem Hospital Regional Cancer Center
Salem, Oregon 97309-5014
United StatesSite Not Available
Oncology Hematology of Lehigh Valley, P.C.
Bethlehem, Pennsylvania 18015
United StatesSite Not Available
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Lifespan: The Miriam Hospital
Providence, Rhode Island 02906
United StatesSite Not Available
Memorial Hospital Cancer Center - Chattanooga
Chattanooga, Tennessee 37404
United StatesSite Not Available
Family Cancer Center
Collierville, Tennessee 38017
United StatesSite Not Available
Baptist Regional Cancer Center
Knoxville, Tennessee 37920
United StatesSite Not Available
West Cancer Clinic
Memphis, Tennessee 38120
United StatesSite Not Available
Center for Oncology Research and Treatment, Medical City Hospital
Dallas, Texas 75230
United StatesSite Not Available
Cancer Therapy and Research Center
San Antonio, Texas 78229
United StatesSite Not Available
Scott and White Memorial Hospital
Temple, Texas 76508
United StatesSite Not Available
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesSite Not Available
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah 84124
United StatesSite Not Available
Seattle Cancer Care Alliance
Seattle, Washington 98109
United StatesSite Not Available

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