Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information

Alternate Title

Comparison of Adjuvant Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients With Resected Stage III Colon Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over NCI NCCTG-N0147 ECOG-N0147

Special Category: CTSU trial

Objectives

1. Compare the overall survival of patients with curatively resected stage III colon cancer when treated with adjuvant irinotecan vs oxaliplatin with fluorouracil and leucovorin calcium vs both regimens given consecutively.
2. Compare the overall survival of patients treated with these regimens with vs without cetuximab.

Secondary

1. Compare the disease-free survival of patients treated with these regimens.
2. Compare the toxic effects of these regimens in these patients.
3. Compare the quality of life, measures of patient satisfaction, nutrition, and cancer risk in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the colon
  • Stage III disease



• No rectal cancer
  • Gross inferior (caudad) margin of the primary tumor must be ≥ 12 cm from the anal verge by rigid proctoscopy



• Tumor must have been completely resected within the past 56 days
  • Must have documented en bloc resection in patients with tumor adherence to adjacent structures
  • Tumor-related obstructions and colonic perforation are allowed



• At least 1 pathologically confirmed positive lymph node
  • No evidence of residual involved lymph node disease



• Synchronous primary colon cancer allowed



• No distant metastatic disease

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent biologic therapy
• No concurrent routine prophylactic colony-stimulating factors
• No concurrent oprelvekin

Chemotherapy

• No prior chemotherapy for colon cancer
• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for colon cancer

Surgery

• See Disease Characteristics

Other

• No prior agents directed against epidermal growth factor-receptor
• No concurrent ketoconazole or other potent inhibitors of CYP3A4 (e.g., itraconazole or voriconazole)
• No other concurrent anticancer therapy
• No concurrent targeted agents

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ lower limit of normal
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL

Hepatic

• Bilirubin ≤ upper limit of normal (ULN)

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No uncontrolled high blood pressure
• No unstable angina
• No symptomatic congestive heart failure
• No myocardial infarction with the past 6 months
• No New York Heart Association class III or IV heart disease

Pulmonary

• No symptomatic pulmonary fibrosis
• No symptomatic interstitial pneumonitis

Immunologic

• No prior allergic reaction (known sensitivity) to chimerized or murine monoclonal antibody therapy
• No documented presence of human anti-mouse antibodies (HAMA)
• No active uncontrolled bacterial, viral, or fungal infection
• HIV negative
• No clinically defined AIDS

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 months after study participation
• No ≥ grade 2 pre-existing peripheral sensory or motor neuropathy
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or lobular carcinoma in situ in 1 breast
• No other concurrent medical condition that would preclude study participation

Projected Accrual

A total of 4,800 patients (800 per treatment arm) will be accrued for this study within 3.5 years.

Outline

This is a randomized, multicenter study. Patients are stratified according to positive lymph node involvement (1-3 vs 4 or more) and histology (high [poorly differentiated or undifferentiated] vs low [well to moderately differentiated]). Patients are randomized to 1 of 6 treatment arms.

• Arm I: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.



• Arm II: Patients receive irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm I. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.



• Arm III: Patients receive the same treatment as in arm I for 6 courses followed by the same treatment as in arm II for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.



• Arm IV: Patients receive cetuximab* IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm I. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.



• Arm V: Patients receive cetuximab* as in arm IV and irinotecan, leucovorin calcium, and fluorouracil as in arm II. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.



• Arm VI: Patients receive cetuximab* as in arm IV and chemotherapy as in arm III.

   [Note: *Cetuximab is administered over 2 hours at a higher dose on day 1 of course 1 only.]

Quality of life is assessed at baseline, before course 6, and at the end of therapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 3 years.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

The study sites listed for this clinical trial are potential study sites; however, not all sites may be participating.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Steven Alberts, MD, Protocol chair		Ph: 507-284-2511
Suresh Nair, MD, Protocol co-chair		Ph: 570-214-9501
Frank Sinicrope, MD, Principal investigator		Ph: 507-284-2511

U.S.A.
Alabama
	Birmingham
	University of Alabama at Birmingham Comprehensive Cancer Center
		Carla Falkson, MD	Ph:  205-975-2691
			Email: cfalkson@uab.edu
	Mobile
	MBCCOP - Gulf Coast
		Paul Schwarzenberger, MD	Ph:  251-544-1013
Arizona
	Scottsdale
	CCOP - Mayo Clinic Scottsdale Oncology Program
		Tom Fitch, MD	Ph:  480-301-9875
California
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - New Patient Services	Ph:  800-826-4673
			Email: becomingapatient@coh.org
	Stanford
	Stanford Cancer Center at Stanford University Medical Center
		Harlan Pinto, MD	Ph:  650-725-9057
Colorado
	Denver
	CCOP - Colorado Cancer Research Program, Incorporated
		Eduardo Pajon, MD	Ph:  303-777-2663
Delaware
	Newark
	CCOP - Christiana Care Health Services
		Stephen Grubbs, MD	Ph:  302-623-4100
District of Columbia
	Washington
	MBCCOP - Howard University Cancer Center
		Lucile Adams-Campbell, PhD	Ph:  202-806-7697
Florida
	Jacksonville
	Mayo Clinic - Jacksonville
		Edith Perez, MD	Ph:  904-953-7283
			Email: perez.edith@mayo.edu
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute
		Cancer Answers	Ph:  800-456-7121
			Email: canceranswers@moffitt.usf.edu
Georgia
	Atlanta
	CCOP - Atlanta Regional
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Winship Cancer Institute of Emory University
		William Wood, MD	Ph:  404-778-5180 888-946-7447
Hawaii
	Honolulu
	MBCCOP - Hawaii
		Brian Issell, MD	Ph:  808-586-3015
			Email: brian@crch.hawaii.edu
Illinois
	Decatur
	CCOP - Central Illinois
		James Wade, MD	Ph:  217-876-6617
			Email: jlwade3@aol.com
	Evanston
	CCOP - Evanston
		Gershon Locker, MD, FACP	Ph:  847-570-2518
			Email: glocker@enh.org
	Peoria
	CCOP - Illinois Oncology Research Association
		John Kugler, MD	Ph:  309-636-3605
	Urbana
	CCOP - Carle Cancer Center
		Kendrith Rowland, MD	Ph:  217-383-4083
			Email: kendrith.rowland@carle.com
Indiana
	Indianapolis
	Indiana University Cancer Center
		Patrick Loehrer, MD	Ph:  317-278-7418 888-600-4822
	South Bend
	CCOP - Northern Indiana CR Consortium
		Rafat Ansari, MD, FACP	Ph:  574-284-7977 800-284-7370
Iowa
	Cedar Rapids
	CCOP - Cedar Rapids Oncology Project
		Martin Wiesenfeld, MD	Ph:  319-363-8303
	Des Moines
	CCOP - Iowa Oncology Research Association
		Roscoe Morton, MD, FACP	Ph:  515-244-7586 888-244-6061
	Sioux City
	Siouxland Hematology-Oncology
		Donald Bruce Wender, MD, PhD	Ph:  712-252-0088
			Email: shoa@pionet.net
Kansas
	Liberal
	Cancer Center of Kansas - Liberal
		Shaker Dakhil, MD	Ph:  620-629-6729
	Wichita
	CCOP - Wichita
		Shaker Dakhil, MD	Ph:  316-268-5784
Louisiana
	New Orleans
	CCOP - Ochsner
		Carl G. Kardinal, MD	Ph:  504-842-3910
	MBCCOP - LSU Health Sciences Center
		Jill Gilbert, MD	Ph:  504-568-5613
			Email: jgilbe@lsuhsc.edu
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Arlene Forastiere, MD	Ph:  410-955-9818
			Email: af@jhmi.edu
Massachusetts
	Boston
	Beth Israel Deaconess Medical Center
		Michael Benjamin Atkins, MD	Ph:  617-667-1930
	Tufts - New England Medical Center
		John Erban, MD	Ph:  617-636-5147
			Email: jerban@tufts-nemc.org
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip Stella, MD	Ph:  877-590-5995
	Kalamazoo
	CCOP - Kalamazoo
		Raymond Lord, MD	Ph:  269-373-7488
			Email: rlord@wmcc.org
Minnesota
	Duluth
	CCOP - Duluth
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
			Email: dnikcevich@smdc.org
	Minneapolis
	University of Minnesota Cancer Center
		George Adams, MD	Ph:  612-625-2410 888-226-2376
			Email: adams002@umn.edu
	Rochester
	Mayo Clinic Cancer Center
		Steven Alberts, MD	Ph:  507-284-2511
		Thomas Habermann, MD	Ph:  507-284-2511
	Saint Cloud
	Coborn Cancer Center
		Harold Windschitl, MD	Ph:  320-229-5199 877-229-4907
			Email: schosp@cloudnet.com
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick Flynn, MD	Ph:  952-993-1517
			Email: patrick.flynn@usoncology.com
Nebraska
	Omaha
	CCOP - Missouri Valley Cancer Consortium
		James Mailliard, MD	Ph:  402-280-4364
			Email: jamailliard@mrcc.cc
Nevada
	Las Vegas
	CCOP - Southern Nevada Cancer Research Foundation
		John Ellerton, MD, CM	Ph:  702-384-0013
			Email: k.vavwagenen@sncrf.com
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Camilo Fadul, MD	Ph:  603-650-6312 800-639-6918
			Email: Camilo.e.fadul@dartmouth.edu
New Jersey
	Hackensack
	CCOP - Northern New Jersey
		Richard Rosenbluth, MD	Ph:  201-996-5917
	New Brunswick
	Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
		Joseph Aisner, MD	Ph:  732-235-7401
			Email: aisnerjo@umdnj.edu
New Mexico
	Albuquerque
	MBCCOP - University of New Mexico HSC
		Cynthia Cathcart, MD	Ph:  505-272-5688
New York
	Bronx
	Albert Einstein Clinical Cancer Center
		Joseph Sparano, MD	Ph:  718-904-2555
			Email: jsparano@montefiore.org
	MBCCOP-Our Lady of Mercy Cancer Center
		Peter Wiernik, MD	Ph:  718-920-1100
			Email: pwiernik@aol.com
	New York
	NYU School of Medicine's Kaplan Comprehensive Cancer Center
		Howard Hochster, MD	Ph:  212-731-5100
			Email: howard.hochster@med.nyu.edu
North Dakota
	Bismarck
	Medcenter One Health System
		Edward Wos, DO	Ph:  701-323-5741
			Email: ejwos@mohs.org
	Fargo
	CCOP - Merit Care Hospital
		Preston Steen, MD	Ph:  701-234-6161
Ohio
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Robert Dreicer, MD, FACP	Ph:  216-445-4623
	MetroHealth's Cancer Care Center at MetroHealth Medical Center
		Edward Mansour, MD	Ph:  216-778-4394
			Email: emansour@metrohealth.org
	Columbus
	CCOP - Columbus
		J. Kuebler, MD, PhD	Ph:  614-443-2267
	Dayton
	CCOP - Dayton
		Howard Gross, MD	Ph:  937-832-1093
	Toledo
	CCOP - Toledo Community Hospital
		Paul Schaefer, MD	Ph:  419-843-6147
Oklahoma
	Tulsa
	CCOP - Oklahoma
		James Lockhart, MD	Ph:  918-491-5878
		Mark Olsen, MD, PhD	Ph:  918-499-2000
			Email: markolsen@usoncology.com
Pennsylvania
	Danville
	CCOP - Geisinger Clinic and Medical Center
		Albert Bernath, MD	Ph:  570-271-6466
	Hershey
	Penn State Cancer Institute at Milton S. Hershey Medical Center
		Witold Rybka, MD, FRCPC	Ph:  717-531-1050
			Email: wrybka@med.hmc.psu.edu
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania Medical Center
		Daniel Haller, MD	Ph:  215-662-6318
	Fox Chase Cancer Center
		Lori Goldstein, MD	Ph:  215-728-2689 888-369-2571
			Email: lj_goldstein@fccc.edu
	Pittsburgh
	Hillman Cancer Center at University of Pittsburgh Cancer Institute
		John Munn Kirkwood, MD	Ph:  412-692-4724
	Wynnewood
	CCOP - MainLine Health
		Paul Gilman, MD	Ph:  610-645-2494
South Carolina
	Spartanburg
	CCOP - Upstate Carolina
		James Dewitt Bearden, MD	Ph:  864-560-7050
South Dakota
	Rapid City
	Rapid City Regional Hospital
		Larry Ebbert, MD	Ph:  605-341-8704
	Sioux Falls
	CCOP - Sioux Community Cancer Consortium
		Loren Tschetter, MD	Ph:  605-328-8044
			Email: cincod@siouxvalley.org
Tennessee
	Nashville
	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
		David Johnson, MD	Ph:  615-343-9454 800-811-8480
			Email: david.h.johnson@vanderbilt.edu
Texas
	Temple
	CCOP - Scott and White Hospital
		Lucas Wong, MD	Ph:  254-724-1053
			Email: lwong@swmail.sw.org
Wisconsin
	Green Bay
	CCOP - St. Vincent Hospital Cancer Center, Green Bay
		Anthony Jaslowski, MD	Ph:  920-884-3135
			Email: tjaslowski@gboncology.com
		Gerald Bayer, MD	Ph:  920-433-8889
	Madison
	University of Wisconsin Comprehensive Cancer Center
		James Stewart, MD	Ph:  608-265-8131 800-622-8922
			Email: stewart@biostat.wisc.edu
	Marshfield
	CCOP - Marshfield Clinic Research Foundation
		Tarit Kumar Banerjee, MD, FACP	Ph:  715-387-5134
	Milwaukee
	Medical College of Wisconsin Cancer Center
		David Vesole, MD, PhD	Ph:  414-805-4626
			Email: dvesole@bmt.mcw.edu
Australia
New South Wales
	Sydney
	Sydney Cancer Centre at Royal Prince Alfred Hospital
		Anne Hamilton, MD, FRACP	Ph:  61-2-9515-5494
	Westmead
	Westmead Hospital
		Richard Kefford, MD, PhD	Ph:  61-2-9845-6033
Peru
	Lima
	Instituto de Enfermedades Neoplasicas
		Carlos Santiago Vallejos-Sologuren, MD	Ph:  51-14-499-137
			Email: postmaster@inen.sld.pe
Puerto Rico
	San Juan
	MBCCOP - San Juan
		Luis Baez-Diaz, MD	Ph:  787-641-3693
			Email: sjccop@prtc.net
Republic of South Africa
	Pretoria
	Pretoria Academic Hospital
		Coenraad Slabber, MD	Ph:  27-12-354-1054

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