Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer

NCT00012389 | Completed Phase 3

• 2 other identifiers: CDR0000068524SANOFI-EFC4585
• Study Type: interventional
• Target: N/A
• Locations: 7 countries
• Sites: 154

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if irinotecan is more effective with or without oxaliplatin in treating metastatic colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with or without oxaliplatin in treating patients who have metastatic colorectal cancer.

Conditions

Colorectal Cancer

Keywords

stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer

Interventions

irinotecan hydrochloride DRUG

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the colon or rectum * Metastatic or recurrent disease that is not amenable to potentially curative treatment * Progressive or recurrent disease during or after 1, and only 1, regimen of fluorouracil with or without leucovorin calcium or during or within 6 months after adjuvant chemotherapy with fluorouracil and leucovorin calcium PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 50-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT/SGPT no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) * Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No unstable angina * No New York Heart Association class III or IV congestive heart failure * No serious cardiac arrhythmia * No history of cardiac toxicity from fluorouracil/leucovorin calcium * No myocardial infarction within past 6 months Pulmonary: * No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: * No uncontrolled predisposing colonic or small bowel disorder * No prior chronic enteropathy, chronic diarrhea, or unresolved bowel obstruction/subobstruction * No diabetes * No active infection * No known current peripheral neuropathy * No concurrent active cancer except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No intolerance of appropriate antiemetics * No history of anaphylaxis or potential intolerance to atropine sulfate or loperamide * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy * No prior irinotecan or oxaliplatin * No other prior chemotherapy agents except fluorouracil with or without leucovorin calcium as first-line therapy for metastatic disease or in the adjuvant setting Endocrine therapy: * Not specified Radiotherapy: * Prior radiotherapy to non-target lesions allowed * No prior radiotherapy to target lesions unless disease progression is documented within the radiation port * At least 3 weeks since prior radiotherapy Surgery: * At least 4 weeks since prior major surgical procedure and recovered * Prior surgery for primary tumor or metastasis allowed Other: * At least 30 days since prior investigational drug * No concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (154)

Comprehensive Cancer Institute of Huntsville

Huntsville, Alabama, 35801, United States

Location

Oncology Center at Providence Park

Mobile, Alabama, 36688, United States

Location

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Citrus Valley Medical Center

Covina, California, 91722, United States

Location

California Cancer Care, Inc.

Greenbrae, California, 94904-2007, United States

Location

Tower Hematology Oncology Medical Group

Los Angeles, California, 90048, United States

Location

Kenmar Research Institute

Los Angeles, California, 90057, United States

Location

Unknown Facility

Los Angeles, California, 90067, United States

Location

Medical Oncology Care Associates

Orange, California, 92868, United States

Location

P.M.K. Medical Group, Inc.

Oxnard, California, 93030, United States

Location

Cancer and Blood Institute of the Desert

Rancho Mirage, California, 92270, United States

Location

Kaiser Permanente-Southern California Permanente Medical Group

San Diego, California, 92120, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, 94589, United States

Location

Colorado Permanente Medical Group, P.C.

Denver, Colorado, 80205, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80220, United States

Location

Whittingham Cancer Center

Norwalk, Connecticut, 06856, United States

Location

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Comprehensive Cancer Care Specialists of Boca Raton

Boca Raton, Florida, 33428, United States

Location

Center for Hematology-Oncology

Boca Raton, Florida, 33486, United States

Location

Southeast Florida Hematology-Oncology Group

Fort Lauderdale, Florida, 33308, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Shands Hospital and Clinics, University of Florida

Gainesville, Florida, 32610-100277, United States

Location

Hematology and Oncology Associates of Jacksonville

Jacksonville, Florida, 32207, United States

Location

University of Florida Health Science Center - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Lakeland Regional Medical Center

Lakeland, Florida, 33804, United States

Location

Lake Heart and Cancer Medical Center

Leesburg, Florida, 34748, United States

Location

Oncology-Hematology Group of South Florida

Miami, Florida, 33176, United States

Location

Hematology and Oncology Consultants, P.A.

Orlando, Florida, 32804, United States

Location

Hematology/Oncology Associates

Port Saint Lucie, Florida, 34952, United States

Location

Oncology & Hematology Associates of West Broward

Tamarac, Florida, 33321, United States

Location

University Community Hospital

Tampa, Florida, 33613, United States

Location

Hematology and Oncology Consultants

Titusville, Florida, 32796, United States

Location

North Idaho Cancer Center

Coeur d'Alene, Idaho, 83814, United States

Location

Northwest Medical Specialists, P.C.

Arlington Heights, Illinois, 60004, United States

Location

Dreyer Medical Clinic

Aurora, Illinois, 60506, United States

Location

Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

Cancer Care Center

New Albany, Indiana, 47150, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Kentuckiana Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Norton Healthcare Pavilion

Louisville, Kentucky, 40202, United States

Location

Veterans Affairs Medical Center - Louisville

Louisville, Kentucky, 40206, United States

Location

Baton Rouge General Medical Center

Baton Rouge, Louisiana, 70806, United States

Location

Louisiana Oncology Associates

Lafayette, Louisiana, 70506, United States

Location

Doctors Hospital of Jefferson

Metairie, Louisiana, 70006, United States

Location

Stanley Scott Cancer Center

New Orleans, Louisiana, 70112, United States

Location

Greater Baltimore Medical Center and Cancer Center

Baltimore, Maryland, 21204, United States

Location

Medical Center of Boston

Boston, Massachusetts, 02120, United States

Location

Berkshire Hematology Oncology, P.C.

Pittsfield, Massachusetts, 01201, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Unknown Facility

Flint, Michigan, 48532, United States

Location

Parker Hughes Cancer Center

Roseville, Minnesota, 55113, United States

Location

Jackson Oncology Associates, PLLC

Jackson, Mississippi, 39202, United States

Location

Veterans Affairs Medical Center - Kansas City

Kansas City, Missouri, 64128, United States

Location

Missouri Cancer Care, P.C.

Saint Charles, Missouri, 63301, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Western Montana Clinic

Missoula, Montana, 59807-7609, United States

Location

Somerset Medical Center

Somerville, New Jersey, 08876, United States

Location

Cooper Cancer Institute

Voorhees Township, New Jersey, 08043, United States

Location

Veterans Affairs Medical Center - Albany

Albany, New York, 12208, United States

Location

Queens Medical Associates, PC

Fresh Meadows, New York, 11365, United States

Location

Queens Hospital Center

Jamaica, New York, 11432, United States

Location

Interlakes Oncology/Hematology PC

Rochester, New York, 14623, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467-2490, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Raleigh Hematology/Oncology Associates - Wake Practice

Raleigh, North Carolina, 27609, United States

Location

Piedmont Hematology-Oncology Associates

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Hematology Oncology Consultants Inc

Columbus, Ohio, 43235, United States

Location

Bend Memorial Clinic

Bend, Oregon, 97701, United States

Location

Kaiser Permanente - Portland

Portland, Oregon, 97227, United States

Location

Pinnacle Health Hospitals

Harrisburg, Pennsylvania, 17105-8700, United States

Location

Abington Hematology Oncology Associates, Incorporated

Meadowbrook, Pennsylvania, 18974, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Lifespan: The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Physicians East - Quadrangle

Greenville, South Carolina, 27834, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29615, United States

Location

Erlanger Health Systems

Chattanooga, Tennessee, 37403, United States

Location

Baptist Regional Cancer Center - Knoxville

Knoxville, Tennessee, 37901, United States

Location

West Clinic

Memphis, Tennessee, 38117, United States

Location

Memphis Cancer Center

Memphis, Tennessee, 38119, United States

Location

Tennessee Oncology, P.L.L.C.

Nashville, Tennessee, 37205, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6307, United States

Location

Lone Star Oncology

Austin, Texas, 78759, United States

Location

Center for Oncology Research and Treatment, Medical City Hospital

Dallas, Texas, 75230, United States

Location

Baptist Health System Cancer Program

San Antonio, Texas, 78205, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Hematology-Oncology Associates of Frederiksburg, Inc.

Fredericksburg, Virginia, 22401, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Advanced Health Care

Milwaukee, Wisconsin, 53209, United States

Location

UW Cancer Center Wausau Hospital

Wausau, Wisconsin, 54401, United States

Location

Irving Cancer Center

Laramie, Wyoming, 82070, United States

Location

Porto Alegre Hospital

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Instituto de Oncologia de Soracaba

Sorocaba, São Paulo, 18030-200, Brazil

Location

Hospital Joao Alves Fiho

Aracaiu-SE, CEP: 49094-970, Brazil

Location

Hospital Socor

Belo Horizonte-MG, CEP: 30180-060, Brazil

Location

Hospital Erastos Gaertner

Curitiba-PR, CEP: 81520-060, Brazil

Location

Instituto Nacional de Cancer

Rio de Janeiro, 20230-130, Brazil

Location

Oncologistas Associados

Rio de Janeiro, CEP: 22260-020, Brazil

Location

Hospital do Cancer A C Comargo

São Paulo, CEP: 01509-010, Brazil

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2R7, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Royal Victoria Hospital, Barrie

Barrie, Ontario, L4M 6M2, Canada

Location

Northeastern Ontario Regional Cancer Centre, Sudbury

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital - Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Charles Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Cite de la Sante de Laval

Laval, Quebec, H7M 3L9, Canada

Location

L'Hotel Dieu de Levis

Lévis, Quebec, G6V 3Z1, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Jewish General Hospital - Montreal

Montreal, Quebec, H3T 1E2, Canada

Location

Hopital Du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Centre Hospitalier de L'Universitaire de Quebec, Pavillon CHUL

Sainte-Foy, Quebec, GIV 4G2, Canada

Location

L'Hopital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Zoom International Incoporated

Saint Jerome Quebec, JYZ 5T3, Canada

Location

Centre of Clinical Oncology and Radiation Oncology

České Budějovice, 370 01, Czechia

Location

Charles University Hospital

Hradec Králové, 500 02, Czechia

Location

Onkologicka Klinka A Onkologicka Lab

Prague, 128 08, Czechia

Location

Fakultni Nemocnice V Motole

Prague, 150 06, Czechia

Location

Semmelweis University

Budapest, 1082, Hungary

Location

National Institute of Oncology

Budapest, 1125, Hungary

Location

Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia

Budapest, H-1032, Hungary

Location

Szent Laszlo Korhaz

Budapest, H-1097, Hungary

Location

Kozponti Honvedkorhaz I. Belgyogyaszat

Budapest, H-1134, Hungary

Location

Debreceni Egyetem Onkologiai Tanzek

Debrecen, H-4012, Hungary

Location

Petz Aladar County Hospital

Gydr, h-9024, Hungary

Location

Maria S. Curie Memorial Institute

Gliwice, 44-101, Poland

Location

Jagiellonian University

Krakow (Cracow), 31-826, Poland

Location

Institute of Oncology

Lodz, 93509, Poland

Location

Wielkopolskie Centrum Onkologii Oddzial Chemioterapii

Poznan, 61-866, Poland

Location

St. Luke's Cancer Center

Guildford, England, GU2 5XX, United Kingdom

Location

St. Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Guy's and St. Thomas' Hospitals NHS Trust

London, England, SE1 9RT, United Kingdom

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Royal Marsden Hospital

Sutton, England, SM2 5PT, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Related Publications (1)

• Haller DG, Rothenberg ML, Wong AO, Koralewski PM, Miller WH Jr, Bodoky G, Habboubi N, Garay C, Olivatto LO. Oxaliplatin plus irinotecan compared with irinotecan alone as second-line treatment after single-agent fluoropyrimidine therapy for metastatic colorectal carcinoma. J Clin Oncol. 2008 Oct 1;26(28):4544-50. doi: 10.1200/JCO.2008.17.1249.

  PMID: 18824706 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Irinotecan; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Daniel G. Haller, MD

  Abramson Cancer Center at Penn Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 3, 2001
• First Posted: January 27, 2003
• Study Start: December 1, 2000
• Study Completion: October 1, 2008
• Last Updated: December 19, 2013

Record last verified: 2002-10

Locations

BR (8); GB (10); PL (4); US (100); CA (21); HU (7); CZ (4)