Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy
Launched by NATIONAL CANCER INSTITUTE (NCI) · Jul 10, 2007
Trial Information
Current as of June 09, 2025
Terminated
Keywords
ClinConnect Summary
PRIMARY OBJECTIVES:
I. Compare progression-free survival of patients with metastatic colorectal cancer that progressed on first-line therapy comprising bevacizumab and FOLFOX, OPTIMOX, or XELOX treated with irinotecan hydrochloride-based chemotherapy and cetuximab with vs without bevacizumab.
II. Compare overall survival of patients treated with these regimens. III. Compare objective tumor response (confirmed and unconfirmed, complete and partial response) in patients with measurable disease treated with these regimens.
IV. Compare the tolerability and safety profile of these regimens in...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients must have metastatic colorectal cancer that has been histologically or cytologically confirmed; confirmation may be from either the primary tumor or a metastasis; patients must have wild type KRAS
- • Patients must be registered within 28 days of documented disease progression on first line chemotherapy with bevacizumab plus either FOLFOX, OPTIMOX, or XELOX; this progression must have occurred within 90 days after the last dose of bevacizumab; patients who discontinued oxaliplatin, continued with 5-FU/LV or capecitabine and bevacizumab and then had subsequent progression while on fluoropyrimidine and bevacizumab are eligible; patients who discontinued bevacizumab due to adverse events in the first-line setting are not eligible
- • Measurable or nonmeasurable disease
- • At least 14 days must have elapsed since the last dose of first line chemotherapy and bevacizumab
- • Patients must not have received prior treatment with irinotecan (either as adjuvant or metastatic treatment)
- • Patients must have no history of prior treatment with cetuximab or other agents targeting VEGF or EGFR (except for bevacizumab)
- • Prior radiotherapy is allowed, provided at least 28 days have elapsed since the last treatment; all adverse events related to radiation therapy must be resolved
- • Prior surgery is allowed, provided at least 28 days have elapsed since any major surgery and patient has recovered from all effects
- • Zubrod performance status 0-2
- • Absolute neutrophil count (ANC) \>= 1,500/mm\^3
- • Platelet count \>= 100,000/mm\^3
- • Hemoglobin \>= 9 g/dL
- • Total bilirubin =\< 1.5 times upper limit of normal (ULN)
- • Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate transaminase (SGPT) =\< 2.5 x IULN; if there are known liver metastases, SGOT or SGPT must be =\< 5 x IULN; these results must be obtained within 28 days prior to registration
- • Serum creatinine =\< IULN or measured or estimated creatinine clearance \>= 60 mL/min
- • Patients must not have a history or known presence of brain metastasis
- • Patients may be on full dose anticoagulation with warfarin provided that the patient has an acceptable International Normalized Ratio (INR) (between 2 and 3), obtained within 28 days prior to registration
- • No clinically relevant bleeding diathesis or coagulopathy
- • Patients must not have experienced nephrotic range proteinuria from prior bevacizumab therapy; urine protein must be screened by urine analysis for Urine Protein Creatinine (UPC) ratio; for UPC ratio \> 0.5, 24-hour urine protein must be obtained and the level must be \< 1,000 mg for patient enrollment; urine protein and creatinine used in calculating the UPC ratio must be obtained within 28 days prior to registration
- • No uncontrolled high blood pressure (BP) (i.e., systolic BP \> 150 mm Hg and diastolic BP \> 90 mm Hg)
- * No cardiovascular event within the past 6 months, including any of the following:
- • Arterial thrombosis
- • Unstable angina
- • Myocardial infarction
- • Cerebrovascular accident
- • Patients must not have New York Heart Association (NYHA) \>= Grade 2 congestive heart failure
- • Patients must not have unstable symptomatic arrhythmia requiring medication; (patients with chronic, controlled arrhythmias such as atrial fibrillation or paroxysmal supraventricular tachycardia \[PSVT\] are eligible)
- • No clinically significant peripheral vascular disease
- • No serious or nonhealing active wound, ulcer, or bone fracture
- • No history of gastrointestinal (GI) perforation while on prior bevacizumab
- • No significant bleeding episodes (e.g., hemoptysis or upper or lower GI bleeding) within the past 6 months unless the source of bleeding has been resected
- • No known hypersensitivity to bevacizumab or known potential hypersensitivity to cetuximab
- • No other concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of anticancer treatment
- • Due to the possibility of harm to a fetus or nursing infant from this treatment regimen, patients must not be pregnant or nursing; women and men of reproductive potential must have agreed to use an effective contraceptive method
- • No other malignancy within the past 5 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ
- • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- • At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Los Angeles, California, United States
Kansas City, Kansas, United States
Denver, Colorado, United States
Denver, Colorado, United States
Lone Tree, Colorado, United States
Thornton, Colorado, United States
Burnsville, Minnesota, United States
Hutchinson, Minnesota, United States
Waconia, Minnesota, United States
Glendale, California, United States
Valdosta, Georgia, United States
South Bend, Indiana, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Boston, Massachusetts, United States
Bangor, Maine, United States
Wichita, Kansas, United States
Temple, Texas, United States
Des Moines, Iowa, United States
Great Falls, Montana, United States
Saint Paul, Minnesota, United States
Seattle, Washington, United States
Greeley, Colorado, United States
Loveland, Colorado, United States
Chanute, Kansas, United States
Dodge City, Kansas, United States
Newton, Kansas, United States
Wellington, Kansas, United States
Winfield, Kansas, United States
Holland, Michigan, United States
Billings, Montana, United States
Bozeman, Montana, United States
Kalispell, Montana, United States
Kalispell, Montana, United States
Delaware, Ohio, United States
Lancaster, Ohio, United States
Seattle, Washington, United States
Spokane, Washington, United States
Sheridan, Wyoming, United States
Duarte, California, United States
Bronx, New York, United States
Elkhart, Indiana, United States
South Bend, Indiana, United States
Clifton Springs, New York, United States
Hayward, California, United States
Oakland, California, United States
Atlanta, Georgia, United States
Lawrenceville, Georgia, United States
Carthage, Illinois, United States
Galesburg, Illinois, United States
Havana, Illinois, United States
Macomb, Illinois, United States
Normal, Illinois, United States
Peoria, Illinois, United States
Princeton, Illinois, United States
Salina, Kansas, United States
Attleboro, Massachusetts, United States
Monroe, Michigan, United States
Bismarck, North Dakota, United States
Chillicothe, Ohio, United States
Fremont, Ohio, United States
Lima, Ohio, United States
Sandusky, Ohio, United States
Tiffin, Ohio, United States
Wauseon, Ohio, United States
Wheat Ridge, Colorado, United States
Eureka, Illinois, United States
Salina, Kansas, United States
Coon Rapids, Minnesota, United States
Canton, Illinois, United States
Pekin, Illinois, United States
Urbana, Illinois, United States
Adrian, Michigan, United States
Edina, Minnesota, United States
Litchfield, Minnesota, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Shakopee, Minnesota, United States
Willmar, Minnesota, United States
Maumee, Ohio, United States
State College, Pennsylvania, United States
Oakland, California, United States
Boulder, Colorado, United States
Peoria, Illinois, United States
Flint, Michigan, United States
Pittsburgh, Pennsylvania, United States
Rapid City, South Dakota, United States
Parkersburg, West Virginia, United States
Grand Forks, North Dakota, United States
Spartanburg, South Carolina, United States
Effingham, Illinois, United States
Fort Scott, Kansas, United States
Independence, Kansas, United States
Lawrence, Kansas, United States
Bozeman, Montana, United States
Havre, Montana, United States
Bellefontaine, Ohio, United States
Mount Vernon, Ohio, United States
Norwalk, Ohio, United States
Portland, Oregon, United States
Casper, Wyoming, United States
Longmont, Colorado, United States
Pascagoula, Mississippi, United States
Rutherfordton, North Carolina, United States
Augusta, Maine, United States
Roseville, California, United States
Canton, Ohio, United States
Missoula, Montana, United States
Minneapolis, Minnesota, United States
Toledo, Ohio, United States
Danville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Woodbury, Minnesota, United States
Jacksonville, Florida, United States
Atlanta, Georgia, United States
South Bend, Indiana, United States
Pittsburg, Kansas, United States
Topeka, Kansas, United States
Columbia, Missouri, United States
Saint Louis, Missouri, United States
Bismarck, North Dakota, United States
Toledo, Ohio, United States
Amarillo, Texas, United States
Seattle, Washington, United States
New Britain, Connecticut, United States
Aurora, Illinois, United States
Joliet, Illinois, United States
Michigan City, Indiana, United States
Canton, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Columbia, South Carolina, United States
Castro Valley, California, United States
Oakland, California, United States
Truckee, California, United States
Coos Bay, Oregon, United States
Denver, Colorado, United States
Englewood, Colorado, United States
Pueblo, Colorado, United States
Ames, Iowa, United States
Topeka, Kansas, United States
Ann Arbor, Michigan, United States
Grand Rapids, Michigan, United States
Fridley, Minnesota, United States
Robbinsdale, Minnesota, United States
Saint Louis Park, Minnesota, United States
Columbus, Ohio, United States
Darby, Pennsylvania, United States
Spartanburg, South Carolina, United States
Green Bay, Wisconsin, United States
Washington, District Of Columbia, United States
Baton Rouge, Louisiana, United States
Glens Falls, New York, United States
Atlanta, Georgia, United States
Riverdale, Georgia, United States
Miami, Florida, United States
Detroit, Michigan, United States
Royal Oak, Michigan, United States
Toledo, Ohio, United States
Charleston, West Virginia, United States
Memphis, Tennessee, United States
Saint Louis, Missouri, United States
Decatur, Georgia, United States
Bismarck, North Dakota, United States
Decatur, Illinois, United States
Decatur, Georgia, United States
Bloomington, Illinois, United States
Galesburg, Illinois, United States
Hopedale, Illinois, United States
Normal, Illinois, United States
Ottawa, Illinois, United States
Ottawa, Illinois, United States
Pekin, Illinois, United States
Peoria, Illinois, United States
Peoria, Illinois, United States
Peoria, Illinois, United States
Peru, Illinois, United States
Spring Valley, Illinois, United States
Fort Wayne, Indiana, United States
El Dorado, Kansas, United States
Kingman, Kansas, United States
Parsons, Kansas, United States
Pratt, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Billings, Montana, United States
Billings, Montana, United States
Billings, Montana, United States
Billings, Montana, United States
Butte, Montana, United States
Great Falls, Montana, United States
Helena, Montana, United States
Kalispell, Montana, United States
Missoula, Montana, United States
Missoula, Montana, United States
Kinston, North Carolina, United States
Effingham, Illinois, United States
Urbana, Illinois, United States
Cedar Rapids, Iowa, United States
Cedar Rapids, Iowa, United States
Cedar Rapids, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Sioux City, Iowa, United States
Sioux City, Iowa, United States
Sioux City, Iowa, United States
Ann Arbor, Michigan, United States
Dearborn, Michigan, United States
Flint, Michigan, United States
Jackson, Michigan, United States
Lansing, Michigan, United States
Saginaw, Michigan, United States
Warren, Michigan, United States
Duluth, Minnesota, United States
Duluth, Minnesota, United States
Duluth, Minnesota, United States
Fergus Falls, Minnesota, United States
Fergus Falls, Minnesota, United States
Saint Paul, Minnesota, United States
Bismarck, North Dakota, United States
Sacramento, California, United States
Mequon, Wisconsin, United States
St. Joseph, Michigan, United States
Sylvania, Ohio, United States
Akron, Ohio, United States
Marietta, Georgia, United States
Des Moines, Iowa, United States
Liberal, Kansas, United States
Adrian, Michigan, United States
Livonia, Michigan, United States
Monroe, Michigan, United States
Pontiac, Michigan, United States
Port Huron, Michigan, United States
Maplewood, Minnesota, United States
Maplewood, Minnesota, United States
Woodbury, Minnesota, United States
Great Falls, Montana, United States
Lincoln, Nebraska, United States
Bowling Green, Ohio, United States
Clyde, Ohio, United States
Elyria, Ohio, United States
Maumee, Ohio, United States
Maumee, Ohio, United States
Oregon, Ohio, United States
Oregon, Ohio, United States
Sandusky, Ohio, United States
Toledo, Ohio, United States
Toledo, Ohio, United States
Toledo, Ohio, United States
Anderson, South Carolina, United States
Fredericksburg, Virginia, United States
Frederick, Maryland, United States
Atlanta, Georgia, United States
Burbank, California, United States
Columbus, Georgia, United States
Rome, Georgia, United States
Kokomo, Indiana, United States
South Bend, Indiana, United States
Iron Mountain, Michigan, United States
Muskegon, Michigan, United States
Cape Girardeau, Missouri, United States
Springfield, Missouri, United States
Missoula, Montana, United States
Sparta, New Jersey, United States
Scranton, Pennsylvania, United States
Upland, Pennsylvania, United States
Green Bay, Wisconsin, United States
Green Bay, Wisconsin, United States
Manitowoc, Wisconsin, United States
Marinette, Wisconsin, United States
Sturgeon Bay, Wisconsin, United States
Wenatchee, Washington, United States
Castro Valley, California, United States
Fremont, California, United States
Greenbrae, California, United States
Oakland, California, United States
Pleasanton, California, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Colorado Springs, Colorado, United States
Lakewood, Colorado, United States
Dover, Delaware, United States
Austell, Georgia, United States
Glens Falls, New York, United States
Pinehurst, North Carolina, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Marietta, Ohio, United States
Newark, Ohio, United States
Springfield, Ohio, United States
Westerville, Ohio, United States
Bellingham, Washington, United States
Seattle, Washington, United States
Seattle, Washington, United States
Eau Claire, Wisconsin, United States
Elkhorn, Wisconsin, United States
Green Bay, Wisconsin, United States
Milwaukee, Wisconsin, United States
Oconto Falls, Wisconsin, United States
Florence, South Carolina, United States
Bremerton, Washington, United States
Mount Vernon, Washington, United States
Seattle, Washington, United States
Hays, Kansas, United States
South Bend, Indiana, United States
Castro Valley, California, United States
Fairfield, California, United States
Marysville, California, United States
Oakland, California, United States
Pleasanton, California, United States
San Pablo, California, United States
Denver, Colorado, United States
Denver, Colorado, United States
Grand Junction, Colorado, United States
Jacksonville, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Springfield, Illinois, United States
Bettendorf, Iowa, United States
Waterloo, Iowa, United States
Escanaba, Michigan, United States
Saint Louis Park, Minnesota, United States
Saint Louis, Missouri, United States
Kearney, Nebraska, United States
Mount Holly, New Jersey, United States
Voorhees, New Jersey, United States
Buffalo, New York, United States
Middletown, New York, United States
Hendersonville, North Carolina, United States
Mansfield, Ohio, United States
Zanesville, Ohio, United States
Lemoyne, Pennsylvania, United States
Media, Pennsylvania, United States
Wilkes Barre, Pennsylvania, United States
Greenville, South Carolina, United States
Kennewick, Washington, United States
Seattle, Washington, United States
Eau Claire, Wisconsin, United States
Janesville, Wisconsin, United States
Elkhart, Indiana, United States
Elkhart, Indiana, United States
Plymouth, Indiana, United States
Saint Joseph, Michigan, United States
Olathe, Kansas, United States
La Porte, Indiana, United States
Mishawaka, Indiana, United States
Goldsboro, North Carolina, United States
Hazleton, Pennsylvania, United States
Columbia, Missouri, United States
Mankato, Minnesota, United States
Greenwood, South Carolina, United States
Poulsbo, Washington, United States
Spokane, Washington, United States
Oakland, California, United States
Easton, Maryland, United States
Hutchinson, Kansas, United States
Sedro Woolley, Washington, United States
La Grange, Illinois, United States
Titusville, Florida, United States
Louisville, Kentucky, United States
Easley, South Carolina, United States
Greenville, South Carolina, United States
Greenville, South Carolina, United States
Greer, South Carolina, United States
Seneca, South Carolina, United States
Spartanburg, South Carolina, United States
Ft. Smith, Arkansas, United States
Pismo Beach, California, United States
Mishawaka, Indiana, United States
Westville, Indiana, United States
Niles, Michigan, United States
Elyria, Ohio, United States
Greenville, South Carolina, United States
Greenville, South Carolina, United States
Greer, South Carolina, United States
Milwaukee, Wisconsin, United States
Patients applied
Trial Officials
Philip Gold
Principal Investigator
SWOG Cancer Research Network
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials