Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
Recruitment status was Active, not recruiting
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| 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:
- Compare the overall survival of patients with metastatic colorectal cancer treated with irinotecan with or without oxaliplatin.
- Compare the response rate, time to tumor-related worsening of symptoms, time to disease progression, onset and duration of responses, and duration of disease stabilization in these patients treated with these regimens.
- Compare the safety of these regimens in these patients.
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.
- Arm I: Patients receive irinotecan IV over 90 minutes on day 1.
- Arm II: Patients receive oxaliplatin IV over 120 minutes followed by irinotecan IV over 30 minutes on day 1.
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:
- 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
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 | |
| Citrus Valley Medical Center | |
| Covina, California, United States, 91722 | |
| California Cancer Care, Inc. | |
| Greenbrae, California, United States, 94904-2007 | |
| Los Angeles, California, United States, 90067 | |
| Kenmar Research Institute | |
| Los Angeles, California, United States, 90057 | |
| Tower Hematology Oncology Medical Group | |
| Los Angeles, California, United States, 90048 | |
| Medical Oncology Care Associates | |
| Orange, California, United States, 92868 | |
| P.M.K. Medical Group, Inc. | |
| Oxnard, California, United States, 93030 | |
| Cancer and Blood Institute of the Desert | |
| Rancho Mirage, California, United States, 92270 | |
| Kaiser Permanente-Southern California Permanente Medical Group | |
| San Diego, California, United States, 92120 | |
| John Wayne Cancer Institute | |
| Santa Monica, California, United States, 90404 | |
| Kaiser Permanente Medical Center - Vallejo | |
| Vallejo, California, United States, 94589 | |
| 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 | |
| Southeast Florida Hematology-Oncology Group | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Florida Cancer Specialists | |
| Fort Myers, Florida, United States, 33901 | |
| Shands Hospital and Clinics, University of Florida | |
| Gainesville, Florida, United States, 32610-100277 | |
| University of Florida Health Science Center - Jacksonville | |
| Jacksonville, Florida, United States, 32209 | |
| Hematology and Oncology Associates of Jacksonville | |
| Jacksonville, Florida, United States, 32207 | |
| Lakeland Regional Medical Center | |
| Lakeland, Florida, United States, 33804 | |
| Lake Heart and Cancer Medical Center | |
| Leesburg, Florida, United States, 34748 | |
| Oncology-Hematology Group of South Florida | |
| Miami, Florida, United States, 33176 | |
| Hematology and Oncology Consultants, P.A. | |
| Orlando, Florida, United States, 32804 | |
| Hematology/Oncology Associates | |
| Port Saint Lucie, Florida, United States, 34952 | |
| Oncology & Hematology Associates of West Broward | |
| Tamarac, Florida, United States, 33321 | |
| University Community Hospital | |
| Tampa, Florida, United States, 33613 | |
| Hematology and Oncology Consultants | |
| Titusville, Florida, United States, 32796 | |
| United States, Idaho | |
| North Idaho Cancer Center | |
| Coeur d'Alene, Idaho, United States, 83814 | |
| United States, Illinois | |
| Northwest Medical Specialists, P.C. | |
| Arlington Heights, Illinois, United States, 60004 | |
| Dreyer Medical Clinic | |
| Aurora, Illinois, United States, 60506 | |
| 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 | |
| Louisiana Oncology Associates | |
| Lafayette, Louisiana, United States, 70506 | |
| Doctors Hospital of Jefferson | |
| Metairie, Louisiana, United States, 70006 | |
| 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 | |
| Medical Center of Boston | |
| Boston, Massachusetts, United States, 02120 | |
| Berkshire Hematology Oncology, P.C. | |
| Pittsfield, Massachusetts, United States, 01201 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Flint, Michigan, United States, 48532 | |
| 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 | |
| Veterans Affairs Medical Center - Kansas City | |
| Kansas City, Missouri, United States, 64128 | |
| Siteman Cancer Center | |
| Saint Louis, Missouri, United States, 63110 | |
| St. John's Mercy Medical Center | |
| Saint Louis, Missouri, United States, 63141 | |
| Missouri Cancer Care, P.C. | |
| St. Charles, Missouri, United States, 63301 | |
| 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 | |
| Somerset Medical Center | |
| Somerville, New Jersey, United States, 08876 | |
| Cooper Cancer Institute | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| Veterans Affairs Medical Center - Albany | |
| Albany, New York, United States, 12208 | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467-2490 | |
| Queens Medical Associates, PC | |
| Fresh Meadows, New York, United States, 11365 | |
| Queens Hospital Center | |
| Jamaica, New York, United States, 11432 | |
| Interlakes Oncology/Hematology PC | |
| Rochester, New York, United States, 14623 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Raleigh Hematology/Oncology Associates - Wake Practice | |
| Raleigh, North Carolina, United States, 27609 | |
| Piedmont Hematology-Oncology Associates | |
| Winston-Salem, North Carolina, United States, 27103 | |
| 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 | |
| Pinnacle Health Hospitals | |
| Harrisburg, Pennsylvania, United States, 17105-8700 | |
| Abington Hematology Oncology Associates, Incorporated | |
| Meadowbrook, Pennsylvania, United States, 18974 | |
| Pennsylvania Oncology Hematology Associates | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| 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 | |
| Erlanger Health Systems | |
| Chattanooga, Tennessee, United States, 37403 | |
| Baptist Regional Cancer Center - Knoxville | |
| Knoxville, Tennessee, United States, 37901 | |
| Memphis Cancer Center | |
| Memphis, Tennessee, United States, 38119 | |
| West Clinic | |
| Memphis, Tennessee, United States, 38117 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6307 | |
| Tennessee Oncology, P.L.L.C. | |
| Nashville, Tennessee, United States, 37205 | |
| United States, Texas | |
| Lone Star Oncology | |
| Austin, Texas, United States, 78759 | |
| Center for Oncology Research and Treatment, Medical City Hospital | |
| Dallas, Texas, United States, 75230 | |
| Baptist Health System Cancer Program | |
| San Antonio, Texas, United States, 78205 | |
| 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 | |
| Porto Alegre Hospital | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90035-003 | |
| Instituto de Oncologia de Soracaba | |
| Sorocaba, Sao Paulo, Brazil, 18030-200 | |
| Hospital Joao Alves Fiho | |
| Aracaiu-SE, Brazil, CEP: 49094-970 | |
| Hospital Socor | |
| Belo Horizonte-MG, Brazil, CEP: 30180-060 | |
| Hospital Erastos Gaertner | |
| Curitiba-PR, Brazil, CEP: 81520-060 | |
| Instituto Nacional de Cancer | |
| Rio de Janeiro, Brazil, 20230-130 | |
| Oncologistas Associados | |
| Rio de Janeiro, Brazil, CEP: 22260-020 | |
| Hospital do Cancer A C Comargo | |
| Sao Paulo, Brazil, CEP: 01509-010 | |
| 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 | |
| Royal Victoria Hospital, Barrie | |
| Barrie, Ontario, Canada, L4M 6M2 | |
| Cancer Care Ontario-London Regional Cancer Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Northeastern Ontario Regional Cancer Centre, Sudbury | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Mount Sinai Hospital - Toronto | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| Hopital Charles Lemoyne | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| 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 | |
| Jewish General Hospital - Montreal | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Hopital Du Sacre-Coeur de Montreal | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Centre Hospitalier Universitaire de Quebec | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| Centre Hospitalier de L'Universitaire de Quebec, Pavillon CHUL | |
| Sainte Foy, Quebec, Canada, GIV 4G2 | |
| L'Hopital Laval | |
| Ste-Foy, Quebec, Canada, G1V 4G5 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Canada | |
| Zoom International Incoporated | |
| St. Jerome Quebec, Canada, JYZ 5T3 | |
| Czech Republic | |
| Centre of Clinical Oncology and Radiation Oncology | |
| Ceske Budejovice, Czech Republic, 370 01 | |
| Charles University Hospital | |
| Hradec Kralove, Czech Republic, 500 02 | |
| Onkologicka Klinka A Onkologicka Lab | |
| Prague, Czech Republic, 128 08 | |
| Fakultni Nemocnice V Motole | |
| Praha, Czech Republic, 150 06 | |
| Hungary | |
| Szent Laszlo Korhaz | |
| Budapest, Hungary, H-1097 | |
| Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia | |
| Budapest, Hungary, H-1032 | |
| Semmelweis University | |
| Budapest, Hungary, 1082 | |
| National Institute of Oncology | |
| Budapest, Hungary, 1125 | |
| Kozponti Honvedkorhaz I. Belgyogyaszat | |
| Budapest, Hungary, H-1134 | |
| Debreceni Egyetem Onkologiai Tanzek | |
| Debrecen, Hungary, H-4012 | |
| Petz Aladar County Hospital | |
| Gydr, Hungary, h-9024 | |
| Poland | |
| Maria S. Curie Memorial Institute | |
| Gliwice, Poland, 44-101 | |
| Jagiellonian University | |
| Krakow (Cracow), Poland, 31-826 | |
| Institute of Oncology | |
| Lodz, Poland, 93509 | |
| Wielkopolskie Centrum Onkologii Oddzial Chemioterapii | |
| Poznan, Poland, 61-866 | |
| United Kingdom | |
| St. Luke's Cancer Center | |
| Guildford, England, United Kingdom, GU2 5XX | |
| St. Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| Charing Cross Hospital | |
| London, England, United Kingdom, W6 8RF | |
| Guy's and St. Thomas' Hospitals NHS Trust | |
| London, England, United Kingdom, SE1 9RT | |
| Maidstone Hospital | |
| Maidstone, England, United Kingdom, ME16 9QQ | |
| Christie Hospital N.H.S. Trust | |
| Manchester, England, United Kingdom, M20 4BX | |
| Derriford Hospital | |
| Plymouth, England, United Kingdom, PL6 8DH | |
| Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| 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
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00012389 History of Changes |
| Other Study ID Numbers: | CDR0000068524, SANOFI-EFC4585 |
| Study First Received: | March 3, 2001 |
| Last Updated: | November 16, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Oxaliplatin |
Irinotecan Camptothecin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013