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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Phase III Randomized Study of Irinotecan Hydrochloride-Based Chemotherapy and Cetuximab With Versus Without Bevacizumab in Patients With Metastatic Colorectal Cancer That Progressed on First-Line Therapy (Treatment Arm III Closed to Accrual as of 4/20/2009)

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	18 and over	NCI	SWOG-S0600 S0600, CALGB-SWOG-S0600, ECOG-SWOG-S0600, CAN-NCIC-SWOG-S0600, NCCTG-SWOG-S0600, NCT00499369

Special Category: NCI Web site featured trial, CTSU trial

Trial Description

Purpose:

Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether irinotecan and cetuximab are more effective with or without bevacizumab in treating metastatic colorectal cancer.

This randomized phase III trial is studying giving irinotecan and cetuximab together with bevacizumab to see how well it works compared with giving irinotecan and cetuximab alone in treating patients with metastatic colorectal cancer that progressed during first-line therapy.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Cancer progressed while receiving first-line therapy with bevacizumab and chemotherapy
• No brain metastases
• At least 2 weeks since the last dose of first-line chemotherapy and bevacizumab
• At least 4 weeks since radiation therapy or surgery
• No previous cetuximab or irinotecan
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of three treatment groups.

Patients in group one will receive a 1½-hour infusion of irinotecan on day 1 with or without a 2-hour infusion of leucovorin on day 1 and a 2-day continuous infusion of fluorouracil on days 1 and 2. They will also receive a 1- to 2-hour infusion of cetuximab on day 1. Treatment may repeat every 2-3 weeks for as long as benefit is shown.

Patients in group two will receive irinotecan alone or together with leucovorin and fluorouracil as in group one. They will also receive a 1- to 2-hour infusion of cetuximab and an infusion of bevacizumab on day 1. Treatment may repeat every 2-3 weeks for as long as benefit is shown.

Patients in group three will receive irinotecan alone or together with leucovorin and fluorouracil as in group one. They will also receive a 1- to 2-hour infusion of cetuximab and an infusion of a higher dose of bevacizumab (higher than in group two) on day 1. Treatment may repeat every 2-3 weeks for as long as benefit is shown. (Group three closed to accrual as of 4/20/2009)

After finishing treatment, patients will be evaluated every 6 months for up to 3 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Philip Gold, MD, Protocol chair		Ph: 206-386-2121 Email: philip.gold@swedish.org
Anthony Shields, MD, PhD, Protocol co-chair		Ph: 313-576-8735; 800-527-6266 Email: shieldsa@karmanos.org

North Central Cancer Treatment Group

Axel Grothey, MD, Protocol chair		Ph: 507-284-2511 Email: grothey.axel@mayo.edu

Cancer and Leukemia Group B

Leonard Saltz, MD, Protocol chair		Ph: 212-639-2501; 800-525-2225

Eastern Cooperative Oncology Group

Steven Cohen, MD, Protocol chair		Ph: 215-728-2450; 888-369-2427 Email: S_Cohen@fccc.edu

NCIC-Clinical Trials Group

Scott Berry, MD, Protocol chair		Ph: 416-480-4270

U.S.A.
Arkansas
	Ft. Smith
	Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
		John Wells, MD	Ph:  479-484-4700
California
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital	Ph:  323-865-0451
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
		Clinical Trials Office - Chao Family Comprehensive Cancer Center	Ph:  877-UC-STUDY
			Email: ucstudy@uci.edu
Illinois
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-6601
	Rockford
	Swedish-American Regional Cancer Center
		Clinical Trials Office - Swedish-American Regional Cancer Center	Ph:  815-489-4413
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	Cedar Rapids
	Cedar Rapids Oncology Associates
		Clinical Trials Office - Cedar Rapids Oncology Associates	Ph:  319-363-2690
	Mercy Regional Cancer Center at Mercy Medical Center
		Martin Wiesenfeld, MD	Ph:  319-363-8303
	Mason City
	Mercy Cancer Center at Mercy Medical Center - North Iowa
		Clinical Trials Office - Mercy Cancer Center at Mercy Medical Center - North Iowa	Ph:  641-422-6304
	Ottumwa
	McCreery Cancer Center at Ottumwa Regional
		Robert Behrens	Ph:  641-684-2946
Louisiana
	Baton Rouge
	Mary Bird Perkins Cancer Center - Baton Rouge
		Robert Veith	Ph:  225-767-0847
	Pennington Cancer Center at Baton Rouge General
		Clinical Trials Office - Pennington Cancer Center at Baton Rouge General	Ph:  225-381-6451
	New Orleans
	MBCCOP - LSU Health Sciences Center
		Robert Veith	Ph:  504-568-5151
	Medical Center of Louisiana - New Orleans
		Robert Veith	Ph:  504-903-2311
Michigan
	Adrian
	Hickman Cancer Center at Bixby Medical Center
		Clinical Trials Office - Hickman Cancer Center at Bixby Medical Center	Ph:  517-265-0116
	Kalamazoo
	Borgess Medical Center
		Raymond Lord, MD	Ph:  269-373-7458
	Bronson Methodist Hospital
		Raymond Lord, MD	Ph:  269-373-7458
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	Lambertville
	Haematology-Oncology Associates of Ohio and Michigan, PC
		Paul Schaefer, MD	Ph:  419-479-5605
	Monroe
	Community Cancer Center of Monroe
		Paul Schaefer, MD	Ph:  419-479-5605
	Mercy Memorial Hospital - Monroe
		Paul Schaefer, MD	Ph:  419-479-5605
New Jersey
	Sparta
	Frederick R. and Betty M. Smith Cancer Treatment Center
		Edith Mitchell, MD, FACP	Ph:  215-955-8874
New York
	Glens Falls
	Charles R. Wood Cancer Center at Glens Falls Hospital
		Clinical Trials Office - Charles R. Wood Cancer Center at Glens Falls Hospital	Ph:  518-926-6700
North Carolina
	Hendersonville
	Pardee Memorial Hospital
		James Radford, MD	Ph:  828-692-8045
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200ext.201
North Dakota
	Bismarck
	Bismarck Cancer Center
		Edward Wos, DO	Ph:  701-323-5741
	Medcenter One Hospital Cancer Care Center
		Edward Wos, DO	Ph:  701-323-5741
	Mid Dakota Clinic, PC
		Clinical Trials Office - Mid Dakota Clinic, PC	Ph:  701-530-6950
	St. Alexius Medical Center Cancer Center
		Clinical Trials Office - St. Alexius Medical Center Cancer Center	Ph:  701-530-6950
Ohio
	Bowling Green
	Wood County Oncology Center
		Paul Schaefer, MD	Ph:  419-479-5605
	Canton
	Aultman Cancer Center at Aultman Hospital
		Clinical Trials Office - Aultman Cancer Center at Aultman Hospital	Ph:  330-363-6891
	Mercy Cancer Center at Mercy Medical Center
		Mitchell Haut, MD	Ph:  330-453-9993
	Clyde
	North Coast Cancer Care - Clyde
		Paul Schaefer, MD	Ph:  419-479-5605
	Elyria
	Hematology Oncology Center
		Paul Schaefer, MD	Ph:  419-479-5605
	Lima
	Lima Memorial Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Maumee
	Northwest Ohio Oncology Center
		Paul Schaefer, MD	Ph:  419-479-5605
		Paul Schaefer, MD	Ph:  419-479-5605
	St. Luke's Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Oregon
	St. Charles Mercy Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo Clinic - Oregon
		Paul Schaefer, MD	Ph:  419-479-5605
	Sandusky
	North Coast Cancer Care, Incorporated
		Paul Schaefer, MD	Ph:  419-479-5605
	Sylvania
	Flower Hospital Cancer Center
		Clinical Trials Office - Flower Hospital Cancer Center	Ph:  419-824-1842
	Tiffin
	Mercy Hospital of Tiffin
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo
	CCOP - Toledo Community Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Medical University of Ohio Cancer Center
		Clinical Trials Office - Medical University of Ohio Cancer Center	Ph:  419-383-6583
	St. Anne Mercy Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	St. Vincent Mercy Medical Center
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo Clinic, Incorporated - Main Clinic
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo Hospital
		Clinical Trials Office - Toledo Hospital	Ph:  419-824-1842
	Wauseon
	Fulton County Health Center
		Clinical Trials Office - Fulton County Health Center	Ph:  419-330-2708
Oklahoma
	Lawton
	Cleo Craig Cancer Research Clinic
		Nadim Nimeh, MD	Ph:  580-536-2121ext.113
Pennsylvania
	Darby
	Mercy Fitzgerald Hospital
		Clinical Trials Office - Mercy Fitzgerald Hospital	Ph:  610-237-4982
	Media
	Riddle Memorial Hospital Cancer Center
		Edith Mitchell, MD, FACP	Ph:  215-955-8874
	Philadelphia
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Clinical Trials Office - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Ph:  215-955-6084
	Scranton
	Hematology and Oncology Associates of Northeastern Pennsylvania
		Edith Mitchell, MD, FACP	Ph:  215-955-8874
Tennessee
	Memphis
	University of Tennessee Cancer Institute - Memphis
		Clinical Trials Office - University of Tennessee Cancer Institute	Ph:  901-448-3303
Virginia
	Fredericksburg
	Fredericksburg Oncology, Incorporated
		Paul Schaefer, MD	Ph:  419-479-5605
Wisconsin
	Chippewa Falls
	Marshfield Clinic - Chippewa Center
		Adedayo Onitilo	Ph:  715-726-4200 800-334-4535
	Eau Claire
	Marshfield Clinic Cancer Care at Regional Cancer Center
		Adedayo Onitilo	Ph:  715-387-5426
	Elkhorn
	Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
		Rossana Madamba	Ph:  262-741-2671 800-252-2990
	Glendale
	Oncology Alliance, SC - Milwaukee - East
		Clinical Trials Office - Oncology Alliance, SC - Milwaukee - East	Ph:  414-906-4480
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph:  608-775-2385
			Email: cancerctr@gundluth.org
	Marshfield
	Marshfield Clinic - Marshfield Center
		Clinical Trials Office - Marshfield Clinic - Marshfield Center	Ph:  800-782-1581 ext. 94457
	Saint Joseph's Hospital
		Adedayo Onitilo	Ph:  715-387-1713
	Milwaukee
	Medical Consultants, Limited
		Jonathan Treisman, MD	Ph:  414-385-3086
	Minocqua
	Marshfield Clinic - Lakeland Center
		Adedayo Onitilo	Ph:  715-358-1000 800-347-0673
	Rhinelander
	Ministry Medical Group at Saint Mary's Hospital
		Adedayo Onitilo	Ph:  715-361-4700 800-866-8673
	Rice Lake
	Marshfield Clinic - Indianhead Center
		Adedayo Onitilo	Ph:  715-236-8100
	Stevens Point
	Saint Michael's Hospital Cancer Center
		Adedayo Onitilo	Ph:  715-346-5000 800-472-9449
	Wausau
	Marshfield Clinic - Wausau Center
		Adedayo Onitilo	Ph:  715-847-3000 800-847-0016
	Weston
	Marshfield Clinic - Weston Center
		Adedayo Onitilo	Ph:  715-393-1000 888-782-8581
	Wisconsin Rapids
	Marshfield Clinic - Wisconsin Rapids Center
		Adedayo Onitilo	Ph:  715-424-8600

Related Information

Featured trial article

Registry Information
Official Title		Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714682) With or Without Bevacizumab (NSC-704965) As Second-Line Therapy for Patients with Metastatic Colorectal Cancer Who Have Progressed on Bevacizumab with Either FOLFOX, OPTIMOX or XELOX
Trial Start Date		2007-06-15
Trial Completion Date		2010-01-15 (estimated)
Registered in ClinicalTrials.gov		NCT00499369
Date Submitted to PDQ		2007-05-17
Information Last Verified		2009-11-25
NCI Grant/Contract Number		CA32102

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