|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00012389 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: irinotecan hydrochloride Drug: oxaliplatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| Official Title: | A Multicenter, Open-Label, Randomized, Two-Arm Study of Irinotecan (CPT-11) Versus the Combination of Oxaliplatin + Irinotecan (CPT-11) as Second-Line Treatment of Metastatic Colorectal Carcinoma |
| Study Start Date: | December 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to Karnofsky performance status (50-60% vs 70-100%), number of metastatic organs involved (1 vs 2 or more), lactic dehydrogenase (no greater than 1.5 times upper limit of normal (ULN) vs greater than 1.5 times ULN), and prior fluorouracil chemotherapy (adjuvant vs first-line treatment for metastatic disease). Patients are randomized to 1 of 2 treatment arms.
Courses repeat in each arm every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days, every 4 weeks for 3 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 596 patients (298 per arm) will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Comprehensive Cancer Institute of Huntsville | |
| Huntsville, Alabama, United States, 35801 | |
| Oncology Center at Providence Park | |
| Mobile, Alabama, United States, 36688 | |
| United States, Arizona | |
| Arizona Clinical Research Center | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Los Angeles, California, United States, 90067 | |
| Kaiser Permanente Medical Center - Vallejo | |
| Vallejo, California, United States, 94589 | |
| Cancer and Blood Institute of the Desert | |
| Rancho Mirage, California, United States, 92270 | |
| Citrus Valley Medical Center | |
| Covina, California, United States, 91722 | |
| John Wayne Cancer Institute | |
| Santa Monica, California, United States, 90404 | |
| California Cancer Care, Inc. | |
| Greenbrae, California, United States, 94904-2007 | |
| Kaiser Permanente-Southern California Permanente Medical Group | |
| San Diego, California, United States, 92120 | |
| Kenmar Research Institute | |
| Los Angeles, California, United States, 90057 | |
| Medical Oncology Care Associates | |
| Orange, California, United States, 92868 | |
| P.M.K. Medical Group, Inc. | |
| Oxnard, California, United States, 93030 | |
| Tower Hematology Oncology Medical Group | |
| Los Angeles, California, United States, 90048 | |
| United States, Colorado | |
| Colorado Permanente Medical Group, P.C. | |
| Denver, Colorado, United States, 80205 | |
| Rocky Mountain Cancer Center | |
| Denver, Colorado, United States, 80218 | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80220 | |
| United States, Connecticut | |
| Whittingham Cancer Center | |
| Norwalk, Connecticut, United States, 06856 | |
| United States, District of Columbia | |
| George Washington University Medical Center | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Center for Hematology-Oncology | |
| Boca Raton, Florida, United States, 33486 | |
| Comprehensive Cancer Care Specialists of Boca Raton | |
| Boca Raton, Florida, United States, 33428 | |
| Florida Cancer Specialists | |
| Fort Myers, Florida, United States, 33901 | |
| Hematology and Oncology Associates of Jacksonville | |
| Jacksonville, Florida, United States, 32207 | |
| Hematology and Oncology Consultants | |
| Titusville, Florida, United States, 32796 | |
| Oncology & Hematology Associates of West Broward | |
| Tamarac, Florida, United States, 33321 | |
| Hematology/Oncology Associates | |
| Port Saint Lucie, Florida, United States, 34952 | |
| Lake Heart and Cancer Medical Center | |
| Leesburg, Florida, United States, 34748 | |
| Lakeland Regional Medical Center | |
| Lakeland, Florida, United States, 33804 | |
| Hematology and Oncology Consultants, P.A. | |
| Orlando, Florida, United States, 32804 | |
| Oncology-Hematology Group of South Florida | |
| Miami, Florida, United States, 33176 | |
| Shands Hospital and Clinics, University of Florida | |
| Gainesville, Florida, United States, 32610-100277 | |
| Southeast Florida Hematology-Oncology Group | |
| Fort Lauderdale, Florida, United States, 33308 | |
| University Community Hospital | |
| Tampa, Florida, United States, 33613 | |
| University of Florida Health Science Center - Jacksonville | |
| Jacksonville, Florida, United States, 32209 | |
| United States, Idaho | |
| North Idaho Cancer Center | |
| Coeur d'Alene, Idaho, United States, 83814 | |
| United States, Illinois | |
| Dreyer Medical Clinic | |
| Aurora, Illinois, United States, 60506 | |
| Northwest Medical Specialists, P.C. | |
| Arlington Heights, Illinois, United States, 60004 | |
| Northwestern Medical Faculty Foundation | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Cancer Care Center | |
| New Albany, Indiana, United States, 47150 | |
| United States, Kentucky | |
| Albert B. Chandler Medical Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0084 | |
| James Graham Brown Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| Kentuckiana Cancer Institute | |
| Louisville, Kentucky, United States, 40202 | |
| Norton Healthcare Pavilion | |
| Louisville, Kentucky, United States, 40202 | |
| Veterans Affairs Medical Center - Louisville | |
| Louisville, Kentucky, United States, 40206 | |
| United States, Louisiana | |
| Baton Rouge General Medical Center | |
| Baton Rouge, Louisiana, United States, 70806 | |
| Doctors Hospital of Jefferson | |
| Metairie, Louisiana, United States, 70006 | |
| Louisiana Oncology Associates | |
| Lafayette, Louisiana, United States, 70506 | |
| Stanley Scott Cancer Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Greater Baltimore Medical Center and Cancer Center | |
| Baltimore, Maryland, United States, 21204 | |
| United States, Massachusetts | |
| Berkshire Hematology Oncology, P.C. | |
| Pittsfield, Massachusetts, United States, 01201 | |
| Medical Center of Boston | |
| Boston, Massachusetts, United States, 02120 | |
| United States, Michigan | |
| Flint, Michigan, United States, 48532 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| United States, Minnesota | |
| Parker Hughes Cancer Center | |
| Roseville, Minnesota, United States, 55113 | |
| United States, Mississippi | |
| Jackson Oncology Associates, PLLC | |
| Jackson, Mississippi, United States, 39202 | |
| United States, Missouri | |
| Missouri Cancer Care, P.C. | |
| St. Charles, Missouri, United States, 63301 | |
| Siteman Cancer Center | |
| Saint Louis, Missouri, United States, 63110 | |
| St. John's Mercy Medical Center | |
| Saint Louis, Missouri, United States, 63141 | |
| Veterans Affairs Medical Center - Kansas City | |
| Kansas City, Missouri, United States, 64128 | |
| United States, Montana | |
| Great Falls Clinic | |
| Great Falls, Montana, United States, 59405 | |
| Western Montana Clinic | |
| Missoula, Montana, United States, 59807-7609 | |
| United States, New Jersey | |
| Cooper Cancer Institute | |
| Voorhees, New Jersey, United States, 08043 | |
| Somerset Medical Center | |
| Somerville, New Jersey, United States, 08876 | |
| United States, New York | |
| Queens Medical Associates, PC | |
| Fresh Meadows, New York, United States, 11365 | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467-2490 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| Queens Hospital Center | |
| Jamaica, New York, United States, 11432 | |
| Interlakes Oncology/Hematology PC | |
| Rochester, New York, United States, 14623 | |
| Veterans Affairs Medical Center - Albany | |
| Albany, New York, United States, 12208 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Piedmont Hematology-Oncology Associates | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Raleigh Hematology/Oncology Associates - Wake Practice | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Hematology Oncology Consultants Inc | |
| Columbus, Ohio, United States, 43235 | |
| United States, Oregon | |
| Bend Memorial Clinic | |
| Bend, Oregon, United States, 97701 | |
| Kaiser Permanente - Portland | |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| Abington Hematology Oncology Associates, Incorporated | |
| Meadowbrook, Pennsylvania, United States, 18974 | |
| Pennsylvania Oncology Hematology Associates | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Pinnacle Health Hospitals | |
| Harrisburg, Pennsylvania, United States, 17105-8700 | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| Lifespan: The Miriam Hospital | |
| Providence, Rhode Island, United States, 02906 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | |
| Greenville, South Carolina, United States, 29615 | |
| Physicians East - Quadrangle | |
| Greenville, South Carolina, United States, 27834 | |
| United States, Tennessee | |
| Baptist Regional Cancer Center - Knoxville | |
| Knoxville, Tennessee, United States, 37901 | |
| Erlanger Health Systems | |
| Chattanooga, Tennessee, United States, 37403 | |
| Memphis Cancer Center | |
| Memphis, Tennessee, United States, 38119 | |
| Tennessee Oncology, P.L.L.C. | |
| Nashville, Tennessee, United States, 37205 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6307 | |
| West Clinic | |
| Memphis, Tennessee, United States, 38117 | |
| United States, Texas | |
| Baptist Health System Cancer Program | |
| San Antonio, Texas, United States, 78205 | |
| Center for Oncology Research and Treatment, Medical City Hospital | |
| Dallas, Texas, United States, 75230 | |
| Lone Star Oncology | |
| Austin, Texas, United States, 78759 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112 | |
| United States, Virginia | |
| Cancer Center at the University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Hematology-Oncology Associates of Frederiksburg, Inc. | |
| Fredericksburg, Virginia, United States, 22401 | |
| United States, Washington | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98101 | |
| United States, Wisconsin | |
| Advanced Health Care | |
| Milwaukee, Wisconsin, United States, 53209 | |
| UW Cancer Center Wausau Hospital | |
| Wausau, Wisconsin, United States, 54401 | |
| United States, Wyoming | |
| Irving Cancer Center | |
| Laramie, Wyoming, United States, 82070 | |
| Brazil | |
| Hospital do Cancer A C Comargo | |
| Sao Paulo, Brazil, CEP: 01509-010 | |
| Hospital Erastos Gaertner | |
| Curitiba-PR, Brazil, CEP: 81520-060 | |
| Hospital Joao Alves Fiho | |
| Aracaiu-SE, Brazil, CEP: 49094-970 | |
| Hospital Socor | |
| Belo Horizonte-MG, Brazil, CEP: 30180-060 | |
| Instituto Nacional de Cancer | |
| Rio de Janeiro, Brazil, 20230-130 | |
| Oncologistas Associados | |
| Rio de Janeiro, Brazil, CEP: 22260-020 | |
| Brazil, Rio Grande do Sul | |
| Porto Alegre Hospital | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90035-003 | |
| Brazil, Sao Paulo | |
| Instituto de Oncologia de Soracaba | |
| Sorocaba, Sao Paulo, Brazil, 18030-200 | |
| Canada | |
| Zoom International Incoporated | |
| St. Jerome Quebec, Canada, JYZ 5T3 | |
| Canada, Alberta | |
| Tom Baker Cancer Center - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| University of Alberta | |
| Edmonton, Alberta, Canada, T6G 2R7 | |
| Canada, Nova Scotia | |
| Nova Scotia Cancer Centre | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Mount Sinai Hospital - Toronto | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Northeastern Ontario Regional Cancer Centre, Sudbury | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Cancer Care Ontario-London Regional Cancer Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Royal Victoria Hospital, Barrie | |
| Barrie, Ontario, Canada, L4M 6M2 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| Centre Hospitalier de L'Universitaire de Quebec, Pavillon CHUL | |
| Sainte Foy, Quebec, Canada, GIV 4G2 | |
| Centre Hospitalier Universitaire de Quebec | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| L'Hopital Laval | |
| Ste-Foy, Quebec, Canada, G1V 4G5 | |
| Hopital Charles Lemoyne | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| Hopital Du Sacre-Coeur de Montreal | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Jewish General Hospital - Montreal | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Cite de la Sante de Laval | |
| Laval, Quebec, Canada, H7M 3L9 | |
| L'Hotel Dieu de Levis | |
| Levis, Quebec, Canada, G6V 3Z1 | |
| Maisonneuve-Rosemont Hospital | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Czech Republic | |
| Centre of Clinical Oncology and Radiation Oncology | |
| Ceske Budejovice, Czech Republic, 370 01 | |
| Charles University Hospital | |
| Hradec Kralove, Czech Republic, 500 02 | |
| Fakultni Nemocnice V Motole | |
| Praha, Czech Republic, 150 06 | |
| Onkologicka Klinka A Onkologicka Lab | |
| Prague, Czech Republic, 128 08 | |
| Hungary | |
| Debreceni Egyetem Onkologiai Tanzek | |
| Debrecen, Hungary, H-4012 | |
| Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia | |
| Budapest, Hungary, H-1032 | |
| Kozponti Honvedkorhaz I. Belgyogyaszat | |
| Budapest, Hungary, H-1134 | |
| National Institute of Oncology | |
| Budapest, Hungary, 1125 | |
| Petz Aladar County Hospital | |
| Gydr, Hungary, h-9024 | |
| Semmelweis University | |
| Budapest, Hungary, 1082 | |
| Szent Laszlo Korhaz | |
| Budapest, Hungary, H-1097 | |
| Poland | |
| Institute of Oncology | |
| Lodz, Poland, 93509 | |
| Jagiellonian University | |
| Krakow (Cracow), Poland, 31-826 | |
| Maria S. Curie Memorial Institute | |
| Gliwice, Poland, 44-101 | |
| Wielkopolskie Centrum Onkologii Oddzial Chemioterapii | |
| Poznan, Poland, 61-866 | |
| United Kingdom, England | |
| Charing Cross Hospital | |
| London, England, United Kingdom, W6 8RF | |
| Christie Hospital N.H.S. Trust | |
| Manchester, England, United Kingdom, M20 4BX | |
| Derriford Hospital | |
| Plymouth, England, United Kingdom, PL6 8DH | |
| Guy's and St. Thomas' Hospitals NHS Trust | |
| London, England, United Kingdom, SE1 9RT | |
| Maidstone Hospital | |
| Maidstone, England, United Kingdom, ME16 9QQ | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| St. Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| St. Luke's Cancer Center | |
| Guildford, England, United Kingdom, GU2 5XX | |
| Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| United Kingdom, Scotland | |
| Aberdeen Royal Infirmary | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Study Chair: | Daniel G. Haller, MD | Abramson Cancer Center of the University of Pennsylvania |
More Information
| Study ID Numbers: | CDR0000068524, SANOFI-EFC4585 |
| Study First Received: | March 3, 2001 |
| Last Updated: | November 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00012389 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
|
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Irinotecan Enzyme Inhibitors Intestinal Diseases Rectal Diseases Pharmacologic Actions |
Camptothecin Intestinal Neoplasms Neoplasms Oxaliplatin Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |