FOLFIRI or FOLFOX With or Without Cetuximab in Patients With Metastatic Adenocarcinoma of the Colon or Rectum
NCT ID: NCT00077233
Last Updated: 2018-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
238 participants
INTERVENTIONAL
2003-12-31
2010-06-30
Brief Summary
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Detailed Description
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Patients were stratified according to prior adjuvant chemotherapy (yes vs no) and prior pelvic radiation (yes vs no). Patients must have completed any major surgery or radiotherapy (eg, chest or bone palliative RT or pelvic RT) ≥ 4 weeks from registration and completed any minor surgery ≥ 2 weeks from registration. Patients must have fully recovered from the procedure and/or radiotherapy. Patients must have initiated treatment within 7 days of registration. Patients were randomized to 1 of 4 treatment arms, please see a description of the treatment regimens in the "Arms" section. In addition, patients received concomitant and supportive therapy as appropriate per the protocol.
OBJECTIVES:
Primary
1\. To determine if the addition of C225 to FOLFIRI or FOLFOX chemotherapy prolongs survival of patients with untreated, advanced or metastatic colorectal cancer.
Secondary
1. To determine if the FOLFIRI and FOLFOX regimens are equivalent in terms of survival as front-line therapy for advanced colorectal patients.
2. To determine the level of EGFR expression in patients with metastatic colorectal cancer.
Patients were followed up to 3 years post-treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: FOLFIRI
Patients receive irinotecan 180 mg/m\^2 over 90 minutes on day 1, then leucovorin 400 mg/m\^2 over 2 hours followed by 5FU 400 mg/m\^2 IV bolus injection then 5FU 2400 mg/m\^2 continuous IV infusion over 46-48 hours repeated every 2 weeks. One cycle of therapy is 8 weeks.
5-FU
IV
irinotecan
IV
leucovorin
IV
Arm B: FOLFIRI + C225
Patients receive irinotecan 180 mg/m\^2 over 90 minutes, then leucovorin 400 mg/m\^2 IV over 2 hours followed by 5FU 400 mg/m\^2 IV bolus injection then 5FU 2400 mg/m\^2 continuous IV infusion over 46-48 hours repeated every 2 weeks. Patients also receive cetuximab 400 mg/m\^2 IV over 120 minutes day 1, then 250 mg/m\^2 IV over 60 minutes weekly. All patients must be premedicated with diphenhydramine hydrochloride 50 mg (or a similar agent) IV prior to the first dose of cetuximab in an effort to prevent a hypersensitivity reaction. Premedication is recommended prior to subsequent doses, but at the Investigator's discretion the dose of diphenhydramine (or a similar agent) may be reduced.
cetuximab
IV
5-FU
IV
irinotecan
IV
leucovorin
IV
Arm C: FOLFOX
Patients receive oxaliplatin 85 mg/m\^2 IV infused over 120 minutes, then leucovorin 400 mg/m\^2 IV over 2 hours followed by 5 FU 400 mg/m\^2 IV bolus injection then 5 FU 2400 mg/m\^2 continuous IV infusion over 46-48 hours every 2 weeks.
5-FU
IV
leucovorin
IV
oxaliplatin
IV
Arm D: FOLFOX + C225
Patients receive oxaliplatin 85 mg/m\^2 IV infused over 120 minutes, then leucovorin 400 mg/m\^2 over 2 hours followed by 5 FU 400 mg/m\^2 IV bolus injection then 5 FU 2400 mg/m\^2 continuous IV infusion over 46-48 hours every 2 weeks. Patients also receive cetuximab 400 mg/m\^2 IV over 120 minutes day 1, then 250 mg/m\^2 IV over 60 minutes weekly. All patients must be premedicated with diphenhydramine hydrochloride 50 mg (or a similar agent) IV prior to the first dose of cetuximab in an effort to prevent a hypersensitivity reaction. Premedication is recommended prior to subsequent doses, but at the Investigator's discretion the dose of diphenhydramine (or a similar agent) may be reduced.
cetuximab
IV
5-FU
IV
leucovorin
IV
oxaliplatin
IV
Interventions
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cetuximab
IV
5-FU
IV
irinotecan
IV
leucovorin
IV
oxaliplatin
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Either an interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease OR
* The primary cancer was stage I.
* Clinicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.
2. No prior treatment for advanced or metastatic colorectal cancer
* Patients may have received prior adjuvant chemotherapy (no more than 6 months or 4 cycles) or radiation with radiosensitizing chemotherapy. The last course of chemotherapy must have concluded \> 12 months prior to registration. Patients may not have previously received irinotecan ≤ or oxaliplatin therapy in either the adjuvant or metastatic setting. No concurrent use of additional investigational agents is allowed while participating in this study.
3. Patients may not have had prior radiotherapy to greater than 25% of bone marrow.
Standard adjuvant rectal cancer chemoradiation will not exclude the patient from protocol entry. Radiation must have concluded ≥ 4 weeks from registration.
4. Patients should have completed any major surgery ≥ 4 weeks from registration. Patients must have completed any minor surgery ≥ 2 weeks from registration. Patients must have fully recovered from the procedure. Insertion of a vascular access device is not considered major or minor surgery.
5. No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years.
6. Age ≥ 18 years
7. CTC (ECOG) performance status of 0-1.
8. No evidence of Gilbert's syndrome - Patients with Gilbert's Syndrome may have a greater risk of irinotecan toxicity due to the abnormal glucuronidation of SN-38. Evidence of Gilbert's Syndrome would include a prior finding of an isolated elevation of indirect bilirubin.
9. Patients must have at least one paraffin block available or appropriate number of unstained slides for analysis of EGFR status.
10. No symptomatic sensory peripheral neuropathy of ≥ grade II at baseline.
11. Non-pregnant and non-lactating
* Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG within 72 hours prior to initiation of treatment. This is because DNA alkylating agents are known to be teratogenic, and the effects of irinotecan, OXAL, 5-FU and C225 on a developing fetus at the recommended therapeutic doses are unknown.
* Women of child bearing potential includes:
* any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or
* is not postmenopausal \[defined as amenorrhea ≥ 12 consecutive months\] or
* women on hormone replacement therapy \[HRT\] with documented serum follicle stimulating hormone (FSH) level \> 35 mIU/mL
* women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (eg, vasectomy), should be considered to be of child bearing potential.
* Should a woman become pregnant or suspect she is pregnant while participating on on this study, she should inform her physician immediately. Because the risk of toxicity of these agents in nursing infants is also unknown, breastfeeding should be discontinued.
12. No known central nervous system metastases or carcinomatous meningitis.
13. No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.
14. No pleural effusion or ascites that causes ≥ grade 2 dyspnea.
15. No predisposing colonic or small bowel disorders in which the symptoms are uncontrolled as indicated by baseline pattern of \> 3 watery or soft stools daily in patients without a colostomy or ileostomy. Patients with a colostomy or ileostomy may be entered at investigator discretion.
16. No prior exposure or known sensitivity to chimerized or murine antibodies, C225 (or other EGFR inhibitors) or any tyrosine kinase inhibitors
17. No significant history of cardiac disease, such as unstable angina, CHF, MI, stroke or a LVEF below the institutional range of normal on a baseline multiple gated acquisition (MUGA) or echocardiogram.
18. Patients must not have an uncontrolled seizure disorder, or active neurological disease.
19. Patients may not have received itraconazole or ketoconazole less than 4 weeks prior to registration.
20. Required Initial Laboratory Values:
* Granulocytes ≥ 1500/ µl
* Hemoglobin ≥ 9.0 gram/dL (patient may be transfused to meet this criterion)
* Platelet count ≥ 100,000/ µl
* Creatinine ≤ 1.5 x Upper limits of normal (ULN)
* Bilirubin ≤ 1.5 mg/dL
* AST ≤ 5.0 x ULN
* Albumin ≥ 2.5 gram/dL
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Bristol-Myers Squibb
INDUSTRY
Eli Lilly and Company
INDUSTRY
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Alan Venook, MD
Role: STUDY_CHAIR
University of California, San Francisco
Locations
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Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States
Naval Medical Center - San Diego
San Diego, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Memorial Regional Cancer Center at Memorial Regional Hospital
Hollywood, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
West Suburban Center for Cancer Care
River Forest, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Baptist Hospital East - Louisville
Louisville, Kentucky, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
NorthEast Oncology Associates - Concord
Concord, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Cape Fear Valley Health System
Fayetteville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital at Ohio State University
Columbus, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States
Martha Jefferson Hospital
Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke, Virginia, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Countries
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References
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Meyerhardt JA, Jackson McCleary N, Niedzwiecki D, et al.: Impact of age and comorbidities on treatment effect, tolerance, and toxicity in metastatic colorectal cancer (mCRC) patients treated on CALGB 80203. [Abstract] J Clin Oncol 27 ( Suppl 15): A-4038, 2009.
Venook A, Niedzwiecki D, Hollis D, et al.: Phase III study of irinotecan/5FU/LV (FOLFIRI) or oxaliplatin/5FU/LV (FOLFOX) ± cetuximab for patients (pts) with untreated metastatic adenocarcinoma of the colon or rectum (MCRC): CALGB 80203 preliminary results. [Abstract] J Clin Oncol 24 (Suppl 18): A-3509, 2006.
Other Identifiers
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CDR0000350016
Identifier Type: OTHER
Identifier Source: secondary_id
CALGB 80203
Identifier Type: -
Identifier Source: org_study_id
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