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Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer Clinical research trials and Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer. Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer  Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
For Condition: stage 4 colon cancer,recurrent rectal cancer,Stage 4 rectal cancer,recurrent colon cancer
Status: No longer recruiting
Sponsor(s): Sanofi-Synthelabo ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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/mm3 - Platelet count at least 100,000/mm3 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DanielHaller, Study Chair, University of Pennsylvania Cancer Center
Tennessee Oncology, P.L.L.C.
Nashville, Tennessee, 37205
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
University of Colorado Cancer Center
Denver, Colorado, 80220
United States
University Community Hospital
Tampa, Florida, 33613
United States
Western Montana Clinic
Missoula, Montana, 59807-7609
United States
Tower Hematology Oncology Medical Group
Los Angeles, California, 90048
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Queens Hospital Center
Jamaica, New York, 11432
United States
Queens Medical Associates, PC
Fresh Meadows, New York, 11365
United States
Whittingham Cancer Center
Norwalk, Connecticut, 06856
United States
Medical Oncology Care Associates
Orange, California, 92868
United States
Citrus Valley Medical Center
Covina, California, 91722
United States
Centre Hospitalier de L'Universitaire de Quebec, Pavillon CHUL
Sainte-Foy, Quebec, GIV 4G2
Canada
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209
United States
Missouri Cancer Care, P.C.
St. Charles, Missouri, 63301
United States
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, G1R 2J6
Canada
Oncology Center at Providence Park
Mobile, Alabama, 36688
United States
Porto Alegre Hospital
Porto Alegre, Rio Grande do Sul, 90035-003
Brazil
Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611
United States
Somerset Medical Center
Somerville, New Jersey, 08876
United States
Instituto de Oncologia de Soracaba
Sorocaba, Sao Paulo, 18030-200
Brazil
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, 21204
United States
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
John Wayne Cancer Institute
Santa Monica, California, 90404
United States
Colorado Permanente Medical Group, P.C.
Denver, Colorado, 80205
United States
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, 33428
United States
Great Falls Clinic
Great Falls, Montana, 59405
United States
Petz Aladar County Hospital
Gydr, , h-9024
Hungary
Parker Hughes Cancer Center
Roseville, Minnesota, 55113
United States
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
Center for Hematology-Oncology
Boca Raton, Florida, 33486
United States
St. John's Mercy Medical Center
St. Louis, Missouri, 63141
United States
Hematology-Oncology Associates of Frederiksburg, Inc.
Fredericksburg, Virginia, 22401
United States
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
L'Hotel Dieu de Levis
Levis, Quebec, G6V 3Z1
Canada
Cancer Care Center
New Albany, Indiana, 47150
United States
New York Medical College
Valhalla, New York, 10595
United States
Hospital Joao Alves Fiho
Aracaiu-SE, , CEP: 49094-970
Brazil
St. Luke's Cancer Center
Guildford, England, GU2 5XX
United Kingdom
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Canada
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, 94589
United States
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Canada
Hematology and Oncology Consultants, P.A.
Orlando, Florida, 32804
United States
St. Bartholomew's Hospital
London, England, EC1A 7BE
United Kingdom
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, 35801
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6307
United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Hospital do Cancer A C Comargo
Sao Paulo, , CEP: 01509-010
Brazil
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Physicians East - Quadrangle
Greenville, South Carolina, 27834
United States
Arizona Clinical Research Center
Tucson, Arizona, 85712
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
Piedmont Hematology-Oncology Associates
Winston Salem, North Carolina, 27103
United States
Berkshire Hematology Oncology, P.C.
Pittsfield, Massachusetts, 01201
United States
Baptist Health System Cancer Program
San Antonio, Texas, 78205
United States
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
United States
Center for Oncology Research and Treatment, Medical City Hospital
Dallas, Texas, 75230
United States
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
Hematology and Oncology Associates of Jacksonville
Jacksonville, Florida, 32207
United States
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
Canada
Hospital Socor
Belo Horizonte-MG, , CEP: 30180-060
Brazil
Stanley Scott Cancer Center
New Orleans, Louisiana, 70112
United States
Charles University Hospital
HRADEC KRALOVE, , 500 02
Czech Republic
North Idaho Cancer Center
Coeur D Alene, Idaho, 83814
United States
Centre of Clinical Oncology and Radiation Oncology
Ceske Budejovice, , 370 01
Czech Republic
Jagiellonian University
Krakow (Cracow), , 31-826
Poland
Lakeland Regional Medical Center
Lakeland, Florida, 33804
United States
Dreyer Medical Clinic
Aurora, Illinois, 60506
United States
Hospital Erastos Gaertner
Curitiba-PR, , CEP: 81520-060
Brazil
Debreceni Egyetem Onkologiai Tanzek
Debrecen, , H-4012
Hungary
Derriford Hospital
Plymouth, England, PL6 8DH
United Kingdom
Louisiana Oncology Associates
Lafayette, Louisiana, 70506
United States
Institute of Oncology
Lodz, , 93509
Poland
National Institute of Oncology
Budapest, , 1125
Hungary
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
United States
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh, North Carolina, 27609
United States
Irving Cancer Center
Laramie, Wyoming, 82070
United States
Medical Center of Boston
Boston, Massachusetts, 02120
United States
Instituto Nacional de Cancer
Rio de Janeiro, , 20230-130
Brazil
University of Alberta
Edmonton, Alberta, T6G 2R7
Canada
Veterans Affairs Medical Center - Louisville
Louisville, Kentucky, 40206
United States
Norton Healthcare Pavilion
Louisville, Kentucky, 40202
United States
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, 17105-8700
United States
Hematology and Oncology Consultants
Titusville, Florida, 32796
United States
Oncology-Hematology Group of South Florida
Miami, Florida, 33176
United States
Erlanger Health Systems
Chattanooga, Tennessee, 37403
United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806
United States
Semmelweis University
Budapest, , 1082
Hungary
Wielkopolskie Centrum Onkologii Oddzial Chemioterapii
Poznan, , 61-866
Poland
Fakultni Nemocnice V Motole
Praha, , 150 06
Czech Republic
Rocky Mountain Cancer Center
Denver, Colorado, 80218
United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, 37901
United States
Montefiore Medical Center
Bronx, New York, 10467-2490
United States
Interlakes Oncology/Hematology PC
Rochester, New York, 14623
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Guy's and St. Thomas' Hospitals NHS Trust
London, England, SE1 9RT
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
United Kingdom
Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia
Budapest, , H-1032
Hungary
California Cancer Care, Inc.
Greenbrae, California, 94904-2007
United States
Northwest Medical Specialists, P.C.
Arlington Heights, Illinois, 60004
United States
Southeast Florida Hematology-Oncology Group
Ft. Lauderdale, Florida, 33308
United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, 19106
United States
Hematology Oncology Consultants Inc
Columbus, Ohio, 43235
United States
Weston Park Hospital
Sheffield, England, S1O 2SJ
United Kingdom
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Lake Heart and Cancer Medical Center
Leesburg, Florida, 34748
United States
Doctors Hospital of Jefferson
Metairie, Louisiana, 70006
United States
Zoom International Incoporated
St. Jerome Quebec, , JYZ 5T3
Canada
Cooper Cancer Institute
Voorhees, New Jersey, 08043
United States
Oncology & Hematology Associates of West Broward
Tamarac, Florida, 33321
United States
Kentuckiana Cancer Institute
Louisville, Kentucky, 40202
United States
Florida Cancer Specialists
Ft. Myers, Florida, 33901
United States
Kozponti Honvedkorhaz I. Belgyogyaszat
Budapest, , H-1134
Hungary
Cite de la Sante de Laval
Laval, Quebec, H7M 3L9
Canada
Maria S. Curie Memorial Institute
Gliwice, , 44-101
Poland
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Kaiser Permanente - Portland
Portland, Oregon, 97227
United States
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Canada
Szent Laszlo Korhaz
Budapest, , H-1097
Hungary
Siteman Cancer Center
St. Louis, Missouri, 63110
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Bend Memorial Clinic
Bend, Oregon, 97701
United States
Advanced Health Care
Milwaukee, Wisconsin, 53209
United States
Royal Marsden Hospital
Sutton, England, SM2 5PT
United Kingdom
Kenmar Research Institute
Los Angeles, California, 90057
United States
Hematology/Oncology Associates
Port Saint Lucie, Florida, 34952
United States
Charing Cross Hospital
London, England, W6 8RF
United Kingdom
West Clinic
Memphis, Tennessee, 38117
United States
Maidstone Hospital
Maidstone, England, ME16 9QQ
United Kingdom
Lone Star Oncology
Austin, Texas, 78759
United States
Oncologistas Associados
Rio de Janeiro, , CEP: 22260-020
Brazil
Onkologicka Klinka A Onkologicka Lab
Prague, , 128 08
Czech Republic
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, P3E 5J1
Canada
UW Cancer Center Wausau Hospital
Wausau, Wisconsin, 54401
United States
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
Abington Hematology Oncology Associates, Incorporated
Meadowbrook, Pennsylvania, 18974
United States
Jewish General Hospital - Montreal
Montreal, Quebec, H3T 1E2
Canada
P.M.K. Medical Group, Inc.
Oxnard, California, 93030
United States
Cancer and Blood Institute of the Desert
Rancho Mirage, California, 92270
United States
L'Hopital Laval
Ste Foy, Quebec, G1V 4G5
Canada
Royal Victoria Hospital, Barrie
Barrie, Ontario, L4M 6M2
Canada
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
Memphis Cancer Center
Memphis, Tennessee, 38119
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
Additional Information:
Study ID Numbers: CDR0000068524; SANOFI-EFC4585
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012389
Other Stage 4 Rectal Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Colorectal Cancer
2. Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer
3. Biological Therapy and Chemotherapy in Treating Patients With Metastatic Kidney Cancer or Colorectal Cancer
4. Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
5. Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer
Related Studies:
Other Stage 4 rectal cancer Clinical Trials
Other Kentucky Clinical Trials
Other Louisville Clinical Trials
Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
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