AzTrials
AzTrials

Colorectal CancerPhase 3NCT00003594

Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

A Phase 3 study testing irinotecan, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 466 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is most effective in treating advanced colorectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
irinotecan, fluorouracil and leucovorin calcium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,691 participants
Where
466 sitesin 4 countries
Study dates
Oct 1998to Oct 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma not curable by surgery or radiotherapy
  • Histological or cytological requirement waived in patients who developed radiological or clinical evidence of metastatic cancer after a prior surgical resection unless:
  • More than 5 years has elapsed since primary surgery OR
  • Primary cancer was stage I or II
  • Site of primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel
  • Measurable or evaluable disease
  • No CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL (transfusion allowed)

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • AST no greater than 5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No uncontrolled hypertension
  • No unstable angina
  • No symptomatic congestive heart failure
  • No myocardial infarction within the past 6 months
  • No serious uncontrolled arrhythmia
  • No New York Heart Association class III or IV cardiac disease

Pulmonary:

  • No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • No pleural effusion or ascites that cause respiratory compromise (grade 2 or worse dyspnea)

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active or uncontrolled infection
  • No symptomatic sensory peripheral neuropathy
  • No known allergy to platinum compounds
  • No history of gastrointestinal bleeding unless it is determined to be acceptable by the enrolling physician
  • No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the uterine cervix, or other resected malignant tumor with less than a 10% probability of tumor relapse within 3 years of diagnosis
  • No medical or psychiatric conditions that would preclude study
  • No colonic or small bowel disorders with uncontrolled symptoms of more than 3 loose stools per day
  • Colostomy or ileostomy allowed at investigator's discretion

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior adjuvant immunotherapy for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease
  • No concurrent sargramostim (GM-CSF)

Chemotherapy:

  • No prior chemotherapy for advanced colorectal cancer
  • No prior standard adjuvant chemotherapy for rectal cancer
  • Prior adjuvant fluorouracil for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy)
  • No prior radiotherapy to more than 15% of bone marrow
  • No prior standard adjuvant radiotherapy for rectal cancer

Surgery:

  • See Disease Characteristics
  • At least 4 weeks since prior major surgery (e.g., laparotomy) (2 weeks for minor surgery) and recovered
  • Insertion of a vascular access device not considered major or minor surgery

Other:

  • No other concurrent investigational agents

Trial locations and contacts

466 sites in 4 countries.

336 sites in 4 countries

United States300 sites

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Akron City Hospital

    Akron, Ohio, 44309

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico, 87108-5138

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • Alexandria Clinic

    Alexandria, Minnesota, 56308

  • Alexandria Radiation Oncology

    Alexandria, Minnesota, 56308

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • McFarland Clinic, P.C.

    Ames, Iowa, 50010

  • William R. Bliss Cancer Center

    Ames, Iowa, 50010

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan, 48105

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0752

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Fox Valley Hematology and Oncology

    Appleton, Wisconsin, 54911

  • Cancer Center of Kansas - Arkansas City

    Arkansas City, Kansas, 67005

  • Memorial Medical Center

    Ashland, Wisconsin, 54806

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Grady Memorial Hospital

    Atlanta, Georgia, 30335

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • Columbia Medical Center of Aurora North Campus

    Aurora, Colorado, 80011

  • Muhlenberg Hospital Center

    Bethlehem, Pennsylvania, 18017

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Veterans Affairs Medical Center - Biloxi

    Biloxi, Mississippi, 39531-2410

  • Veterans Affairs Medical Center - Birmingham

    Birmingham, Alabama, 35233-1996

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501-4445

  • Medcenter One Health System

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, P.C.

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center

    Bismarck, North Dakota, 58502

  • BroMenn Lifecare Center

    Bloomington, Illinois, 61701-3081

  • St. Joseph's Hospital Medical Center

    Bloomington, Illinois, 61701

  • New England Medical Center Hospital

    Boston, Massachusetts, 02111

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Brainerd Medical Center

    Brainerd, Minnesota, 56401

  • St. Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Bristol Hospital

    Bristol, Connecticut, 06011-0977

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Mercy Ireland Cancer Center

    Canton, Ohio, 44708

  • Aultman Cancer Center

    Canton, Ohio, 44710

  • Marion Community Hospital

    Carbondale, Pennsylvania, 18407

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52406

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Center for Cancer And Hematologic Disease

    Cherry Hill, New Jersey, 08046

  • Hematology-Oncology Associates of Illinois

    Chicago, Illinois, 60611-2998

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

    Chicago, Illinois, 60611-3013

  • Hematology Oncology Associates of Illinois - Lake Shore Dr

    Chicago, Illinois, 60611

  • Veterans Affairs Medical Center - Lakeside Chicago

    Chicago, Illinois, 60611

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • Mercy Hospital and Medical Center

    Chicago, Illinois, 60616

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220-2288

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio, 45267-0502

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Penrose Cancer Center

    Colorado Springs, Colorado, 80933

  • Veterans Affairs Medical Center - Columbia (Truman Memorial)

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Alegent Health Southwest Iowa Medical Center

    Council Bluffs, Iowa, 51503

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • CCOP - Colorado Cancer Research Program, Inc.

    Denver, Colorado, 80209-5031

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian-St Luke's Medical Center

    Denver, Colorado, 80218

  • St. Joseph Hospital

    Denver, Colorado, 80218

  • HealthOne Rose Medical Center

    Denver, Colorado, 80220

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Des Moines General Hospital

    Des Moines, Iowa, 50309

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates

    Des Moines, Iowa, 50314

  • Mercy Hospital Medical Center

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316-2392

  • Holy Family Medical Center

    Des Plaines, Illinois, 60016

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan, 48201-1932

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Radiation Oncology Center

    Dodge City, Kansas, 67801

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Cancer Center and Beckman Research Institute, City of Hope

    Duarte, California, 91010-3000

  • DuBois Regional Medical Center

    DuBois, Pennsylvania, 15801-0447

  • Duluth Clinic

    Duluth, Minnesota, 55805

  • Miller-Dwan Medical Center

    Duluth, Minnesota, 55805

  • St. Mary's/Duluth Clinic Health System

    Duluth, Minnesota, 55805

  • Veterans Affairs Medical Center - Durham

    Durham, North Carolina, 27705

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Luther Hospital

    Eau Claire, Wisconsin, 54703

  • Midelfort Clinic

    Eau Claire, Wisconsin, 54703

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • St. Anthony's Memorial Hospital

    Effingham, Illinois, 62401

  • Trinitas Hospital - Jersey Street Campus

    Elizabeth, New Jersey, 07201

  • Northwest Oncology and Hematology, S.C.

    Elk Grove Village, Illinois, 60007

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Eureka Hospital

    Eureka, Illinois, 61530

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • Therapy Associates Hematology/Oncology

    Evansville, Indiana, 47715

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • Meritcare Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • University of Connecticut Health Center

    Farmington, Connecticut, 06360-7106

  • Fergus Falls Medical Group

    Fergus Falls, Minnesota, 56537

  • Woman Wise Blanchard Valley Regional Health Center

    Findlay, Ohio, 45840

  • Hunterdon Regional Cancer Center

    Flemington, New Jersey, 08822

  • Genesee Regional Medical Center

    Flint, Michigan, 48503

  • Rocky Mountain Cancer Centers - Northern Colorado

    Fort Collins, Colorado, 80524-4038

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Poudre Valley Radiation Oncology

    Fort Collins, Colorado, 80528

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905-5650

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Fremont Area Medical Center

    Fremont, Nebraska, 68025-2387

  • Fremont Memorial Hospital

    Fremont, Ohio, 43420

  • Mercy/Unity Hospitals

    Fridley, Minnesota, 55432

  • University of Florida - Gainesville

    Gainesville, Florida, 32610-0277

  • Galesburg Clinic

    Galesburg, Illinois, 61401

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61402

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0209

  • Glenbrook Hospital

    Glenview, Illinois, 60025

  • Altru Health Systems

    Grand Forks, North Dakota, 58201

  • Altru Cancer Center

    Grand Forks, North Dakota, 58206

  • CCOP - Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-3508

  • UPMC Horizon

    Greenville, Pennsylvania, 16125

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Halstead Cancer Center of Kansas

    Halstead, Kansas, 67056

  • Pinnacle Health Hospitals

    Harrisburg, Pennsylvania, 17105-8700

  • St. Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Mason District Hospital

    Havana, Illinois, 62644

  • Central Mesabi Medical Center

    Hibbing, Minnesota, 55746

  • Duluth Clinic - Hibbing

    Hibbing, Minnesota, 55746

  • Radiation Therapy Center

    Hibbing, Minnesota, 55746

  • Hematology Oncology Associates of Illinois-Highland Park

    Highland Park, Illinois, 60035

  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

    Hines, Illinois, 60141

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Wayne Memorial Hospital

    Honesdale, Pennsylvania, 18431-1498

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Hopedale Medical Complex Hospital

    Hopedale, Illinois, 61747

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Holden Comprehensive Cancer Center at The University of Iowa

    Iowa City, Iowa, 52242-1009

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi, 39216

  • Baptist Regional Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • University of Florida Health Science Center - Jacksonville

    Jacksonville, Florida, 32209

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Faulkner Hospital

    Jamaica Plain, Massachusetts, 02130

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts, 02130

  • UPCI @ UPMC Lee Hospital

    Johnstown, Pennsylvania, 15901

  • Conemaugh Memorial Hospital

    Johnstown, Pennsylvania, 15905

  • Silver Cross Hospital

    Joliet, Illinois, 60432

  • Joliet Oncology/Hematology Associates, Ltd.

    Joliet, Illinois, 60435

  • Saint Joseph Medical Center

    Joliet, Illinois, 60435

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048-1666

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • Office of Sharon Cole, M.D.

    Kenton, Ohio, 43326

  • CCOP - Dayton

    Kettering, Ohio, 45429

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas - Kingman

    Kingman, Kansas, 67068

  • Armstrong County Memorial Hospital

    Kittanning, Pennsylvania, 16201-8808

  • Franciscan Skemp Healthcare

    La Crosse, Wisconsin, 54601-4796

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • University of California San Diego Cancer Center

    La Jolla, California, 92093-0658

  • Oncology Institute of Greater Lafayette

    Lafayette, Indiana, 47904

  • Deerpath Medical Associates

    Lake Forest, Illinois, 60045

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604-3555

  • Saint Mary Regional Center

    Langhorne, Pennsylvania, 19047

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48909

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Latrobe Area Hospital

    Latrobe, Pennsylvania, 15650

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756-0002

  • Central Pennsylvania Hematology and Medical Oncology Associates

    Lemoyne, Pennsylvania, 17043

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40511-1093

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • Liberal Cancer Center of Kansas

    Liberal, Kansas, 67901

  • North Shore Oncology Hematology Associates

    Libertyville, Illinois, 60048

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Bryan LGH Medical Center

    Lincoln, Nebraska, 68502-3780

  • Prairie View Clinic

    Lincoln, Nebraska, 68506-5247

  • Bryan LGH Medical Center East

    Lincoln, Nebraska, 68506

  • Office of Susan Hansen, M.D.

    Lincoln, Nebraska, 68506

  • St. Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Wedgewood Medical Center

    Lincoln, Nebraska, 68510

  • Southeast Nebraska Hematology

    Lincoln, Nebraska, 68516

  • Southeast Nebreska Hematology-Oncology Consultants, PC

    Lincoln, Nebraska, 68516

  • Williamsburg Radiation Oncology Center

    Lincoln, Nebraska, 68516

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Veterans Affairs Medical Center - Little Rock (McClellan)

    Little Rock, Arkansas, 72205

  • Veterans Affairs Medical Center - Long Beach

    Long Beach, California, 90822

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • Veterans Affairs Medical Center - West Los Angeles

    Los Angeles, California, 90073

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • Veterans Affairs Medical Center - Madison

    Madison, Wisconsin, 53705

  • Dean Medical Center

    Madison, Wisconsin, 53715

  • Meriter Hospital

    Madison, Wisconsin, 53715

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Office of E. Michael Lodish

    Madison Heights, Michigan, 48071-3457

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Schneider Children's Hospital at North Shore

    Manhasset, New York, 11030

  • St. John's Hospital

    Maplewood, Minnesota, 55109

  • CCOP - Marshfield Medical Research and Education Foundation

    Marshfield, Wisconsin, 54449

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California, 94553

  • Mercy Cancer Center

    Mason City, Iowa, 50401

  • North West Ohio Oncology Center

    Maumee, Ohio, 43537

  • Saint Luke's Hospital

    Maumee, Ohio, 43537

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Lawrence Memorial Hospital of Medford/Hallmark Health Systems

    Medford, Massachusetts, 02155

  • Hematology/Oncology Associates of Illinois, LLC

    Melrose Park, Illinois, 60160

  • University of Tennessee, Memphis Cancer Center

    Memphis, Tennessee, 38103

  • Veterans Affairs Medical Center - Memphis

    Memphis, Tennessee, 38104

  • Mendota Community Hospital

    Mendota, Illinois, 61342

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • South Jersey Regional Cancer Center

    Millville, New Jersey, 08332

  • Aurora Sinai Samaritan Medical Center

    Milwaukee, Wisconsin, 53201-0342

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • North Memorial Research Center

    Minneapolis, Minnesota, 55442-2900

  • Fairview University Medical Center - Riverside Campus

    Minneapolis, Minnesota, 55454-1395

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Community Memorial Hospital

    Missouri Valley, Iowa, 51555-1199

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36688

  • Trinity Medical Center

    Moline, Illinois, 61265-1291

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Community Hospital of the Monterey Peninsula

    Monterey, California, 93940

  • Morris Hospital

    Morris, Illinois, 60450

  • Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

    Mount Holly, New Jersey, 08060

  • New Britain General Hospital

    New Britain, Connecticut, 06050

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Lawrence and Memorial Hospital

    New London, Connecticut, 06320

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Veterans Affairs Medical Center - New York

    New York, New York, 10010

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

    New York, New York, 10016

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Presbyterian Hospital - Cornell Campus

    New York, New York, 10021

  • Mount Sinai Medical Center, NY

    New York, New York, 10029

  • Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • William W. Backus Hospital

    Norwich, Connecticut, 06360

  • Hematology Oncology Associates of Illinois, LLC

    Oak Park, Illinois, 60304

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104

  • Veterans Affairs Medical Center - Oklahoma City

    Oklahoma City, Oklahoma, 73104

  • Veterans Affairs Medical Center - Omaha

    Omaha, Nebraska, 68105

  • Oncology Hematology West, P.C.

    Omaha, Nebraska, 68114

  • Alegent Health - Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Creighton University Cancer Center

    Omaha, Nebraska, 68131-2197

  • St. Joseph Hospital

    Omaha, Nebraska, 68131-2197

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-3330

  • Burgess Health Center

    Onawa, Iowa, 51040

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • St. Charles Hospital

    Oregon, Ohio, 43616

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology & Hematology of Ottumwa, PC

    Ottumwa, Iowa, 52501

  • Ottumwa Regional Health Center

    Ottumwa, Iowa, 52501

  • Veterans Affairs Medical Center - Palo Alto

    Palo Alto, California, 94304

  • Alegent Health-Midlands Community Hospital

    Papillion, Nebraska, 68046-4194

  • Pekin Hospital

    Pekin, Illinois, 61554

  • Illinois Oncology Research Association

    Peoria, Illinois, 61602

  • Oncology/Hematology Associates of Central Illinois, P.C.

    Peoria, Illinois, 61602

  • Affiliated Urology Specialists

    Peoria, Illinois, 61603

  • Midwest Urological Group

    Peoria, Illinois, 61603

  • Peoria Urological Associates

    Peoria, Illinois, 61614

  • Proctor Hospital

    Peoria, Illinois, 61614

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Midwest Radiation Oncology Physicians

    Peoria, Illinois, 61636

  • St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

Other trials in United States

Canada31 sites

  • William Osler Health Centre

    Brampton, Ontario, L6W 2Z8

  • Queen Elizabeth Hospital, PEI

    Charlottetown, Prince Edward Island, C1A 8T5

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Trillium Health Centre

    Mississauga, Ontario, L5B 1B8

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L-4M1

  • CHUM Hopital Saint-Luc

    Montreal, Quebec, H2X 3J4

  • Nanaimo Cancer Clinic

    Nanaimo, British Columbia, V9S 2B7

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

  • Lions Gate Hospital

    North Vancouver, V7L 2P9

  • Peterborough Oncology Clinic

    Peterborough, Ontario, K9H 7B6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Algoma District Medical Group

    Sault Ste. Marie, Ontario, P6B 1Y5

  • Hotel Dieu Health Sciences Hospital - Niagara

    St. Catharines, Ontario, L2R 5K3

  • L'Hopital Laval

    Ste-Foy, Quebec, G1V 4G5

  • British Columbia Cancer Agency - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Northwestern Ontario Regional Cancer Centre, Thunder Bay

    Thunder Bay, Ontario, P7A 7T1

  • Mount Sinai Hospital - Toronto

    Toronto, Ontario, M5G 1X5

  • Saint Joseph's Health Centre - Toronto

    Toronto, Ontario, M6R 1B5

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

  • British Columbia Cancer Agency - Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 6V5

  • Humber River Regional Hospital

    Weston, Ontario, M9N 1N8

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Puerto Rico3 sites

  • Centro Mamografia Hospital Oncologico

    Hato Rey, 00919-1811

  • Veterans Affairs Medical Center - San Juan

    San Juan, 00927-5800

  • San Juan City Hospital

    San Juan, 00936-7344

Other trials in Puerto Rico

South Africa2 sites

  • Medical Oncology Centre of Rosebank

    Johannesburg, 2193

  • Pretoria Academic Hospitals

    Pretoria, 0001

Other trials in South Africa

About this study

Official title: A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is most effective in treating advanced colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy.

Read the detailed description

OBJECTIVES:

  • Compare the time to progression in patients with locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma treated with combinations of oxaliplatin, fluorouracil, leucovorin calcium, and irinotecan.
  • Compare the quality of life, response rate, time to treatment failure, and overall survival in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior adjuvant chemotherapy (yes vs no), prior immunotherapy (yes vs no), and age (under 65 vs 65 and over). Patients are randomized to one of three treatment arms.

Only arm II remains open to accrual.

  • Arm I (Saltz regimen): Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest. Courses repeat every 6 weeks. (Arm I closed to accrual as of March 15, 2002.)
  • Arm II (FOLFOX4 regimen): Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks.
  • Arm III (oxaliplatin plus irinotecan): Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on day 1. Courses repeat every 3 weeks. (Arm III closed to accrual as of March 15, 2002.) Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 825 patients (275 per arm) have been accrued for this study thus far. Additional patients are being accrued on arm II. (Arms I and III closed to accrual as of March 15, 2002.)

Keywords
stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00003594
Study groupRoleWhat they receive
irinotecan + leucovorin + fluorouracilExperimentalPatients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest. Courses repeat every 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Receives: Drug: irinotecan; Drug: fluorouracil; Drug: leucovorin calcium
oxaliplatin + leucovorin + fluorouracilExperimentalPatients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Receives: Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin
oxaliplatin + irinotecanExperimentalPatients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on day 1. Courses repeat every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Receives: Drug: irinotecan; Drug: oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time to progression

    Measured: Up to 5 years

Secondary outcomes (4)

  1. overall survival

    Measured: Up to 5 years

  2. time to treatment failure

    Measured: Up to 5 years

  3. response rate

    Measured: Up to 5 years

  4. quality of life

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2003 (estimated)
  2. Study startOct 1998
  3. Primary completionOct 2004
  4. Study completionOct 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,691 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003594
Sponsor's protocol ID
NCCTG-N9741
Other IDs
CDR0000066665, CAN-NCIC-CO13
Status last verified
Apr 2020
First submitted
1 Nov 1999
Last updated
29 Apr 2020
Results posted
No
Data monitoring committee
No

Publications

  • Franko J, Shi Q, Goldman CD, Pockaj BA, Nelson GD, Goldberg RM, Pitot HC, Grothey A, Alberts SR, Sargent DJ. Treatment of colorectal peritoneal carcinomatosis with systemic chemotherapy: a pooled analysis of north central cancer treatment group phase III trials N9741 and N9841. J Clin Oncol. 2012 Jan 20;30(3):263-7. doi: 10.1200/JCO.2011.37.1039. Epub 2011 Dec 12.

    PubMed 22162570

  • An MW, Mandrekar SJ, Branda ME, Hillman SL, Adjei AA, Pitot HC, Goldberg RM, Sargent DJ. Comparison of continuous versus categorical tumor measurement-based metrics to predict overall survival in cancer treatment trials. Clin Cancer Res. 2011 Oct 15;17(20):6592-9. doi: 10.1158/1078-0432.CCR-11-0822. Epub 2011 Aug 31.

    PubMed 21880789

  • Campbell ME, Mandrekar SJ, Hillman SL, et al.: What is the added value of actual tumor measurements (TM) in predicting overall survival (OS)? The North Central Cancer Treatment Group (NCCTG) findings. [Abstract] J Clin Oncol 26 (Suppl 15): A-6520, 2008.

  • Grothey A, Hedrick EE, Mass RD, Sarkar S, Suzuki S, Ramanathan RK, Hurwitz HI, Goldberg RM, Sargent DJ. Response-independent survival benefit in metastatic colorectal cancer: a comparative analysis of N9741 and AVF2107. J Clin Oncol. 2008 Jan 10;26(2):183-9. doi: 10.1200/JCO.2007.13.8099.

    PubMed 18182660

  • Grothey A, Hedrick EE, Mass RD, et al.: Response rate using conventional criteria is a poor surrogate for clinical benefit on progression-free (PFS) and overall survival (OS) in metastatic colorectal cancer (mCRC): a comparative analysis of N9741 and AVF2107. [Abstract] J Clin Oncol 24 (Suppl 18): A-3516, 2006.

  • Goldberg R. Oxaliplatin in colorectal cancer: current studies. Oncology (Williston Park). 2000 Dec;14(12 Suppl 11):42-7.

    PubMed 11204663

  • Heun JM, Grothey A, Branda ME, Goldberg RM, Sargent DJ. Tumor status at 12 weeks predicts survival in advanced colorectal cancer: findings from NCCTG N9741. Oncologist. 2011;16(6):859-67. doi: 10.1634/theoncologist.2011-0064. Epub 2011 May 31.

    PubMed 21632455

  • Ng K, Sargent DJ, Goldberg RM, Meyerhardt JA, Green EM, Pitot HC, Hollis BW, Pollak MN, Fuchs CS. Vitamin D status in patients with stage IV colorectal cancer: findings from Intergroup trial N9741. J Clin Oncol. 2011 Apr 20;29(12):1599-606. doi: 10.1200/JCO.2010.31.7255. Epub 2011 Mar 21.

    PubMed 21422438

  • Goldberg RM, Sargent DJ, McLeod H. Leveraging learning from a phase III colorectal cancer clinical trial: outcomes, methodology, meta-analysis and pharmacogenetics. Trans Am Clin Climatol Assoc. 2010;121:21-32; discussion 32-3.

    PubMed 20697547

  • McLeod HL, Sargent DJ, Marsh S, Green EM, King CR, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Thibodeau SN, Grothey A, Morton RF, Goldberg RM. Pharmacogenetic predictors of adverse events and response to chemotherapy in metastatic colorectal cancer: results from North American Gastrointestinal Intergroup Trial N9741. J Clin Oncol. 2010 Jul 10;28(20):3227-33. doi: 10.1200/JCO.2009.21.7943. Epub 2010 Jun 7.

    PubMed 20530282

  • Goldberg RM, Sargent DJ, Morton RF, Green E, Sanoff HK, McLeod H, Buckner J. NCCTG Study N9741: leveraging learning from an NCI Cooperative Group phase III trial. Oncologist. 2009 Oct;14(10):970-8. doi: 10.1634/theoncologist.2009-0175. Epub 2009 Oct 14.

    PubMed 19828593

  • Sanoff HK, Sargent DJ, Green EM, McLeod HL, Goldberg RM. Racial differences in advanced colorectal cancer outcomes and pharmacogenetics: a subgroup analysis of a large randomized clinical trial. J Clin Oncol. 2009 Sep 1;27(25):4109-15. doi: 10.1200/JCO.2009.21.9527. Epub 2009 Jul 27.

    PubMed 19636001

  • Fuchs CS, Goldberg RM, Sargent DJ, Meyerhardt JA, Wolpin BM, Green EM, Pitot HC, Pollak M. Plasma insulin-like growth factors, insulin-like binding protein-3, and outcome in metastatic colorectal cancer: results from intergroup trial N9741. Clin Cancer Res. 2008 Dec 15;14(24):8263-9. doi: 10.1158/1078-0432.CCR-08-0480. Epub 2008 Dec 10.

    PubMed 19073970

  • Sanoff HK, Sargent DJ, Campbell ME, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Goldberg RM. Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Clin Oncol. 2008 Dec 10;26(35):5721-7. doi: 10.1200/JCO.2008.17.7147. Epub 2008 Nov 10.

    PubMed 19001325

  • Sargent DJ, Campbell M, Grothey A, et al.: Overall and 12 week tumor response versus actual tumor measurements as predictors of overall survival (OS) in advanced colorectal cancer (ACRC): findings from NCCTG N9741. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-446, 2008.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing irinotecan, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 466 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 466 sites in United States, Canada, Puerto Rico, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time to progression (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003594, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.

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