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Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer Clinical research trials and Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer. Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer  Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer
Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer
For Condition: recurrent colon cancer,adenocarcinoma of the rectum,adenocarcinoma of the colon,Stage 4 rectal cancer,recurrent rectal cancer,stage 4 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 which regimen of chemotherapy is more effective for metastatic colorectal cancer. PURPOSE: Phase III trial to compare the effectiveness of three chemotherapy regimens in treating patients who have metastatic colorectal cancer.
Details: OBJECTIVES: I. Compare the overall survival of patients with metastatic colorectal carcinoma treated with fluorouracil and leucovorin calcium with vs without oxaliplatin vs oxaliplatin alone. II. Compare the response rate, time to tumor-related symptomatic worsening, time to disease progression, onset and duration of complete and partial responses, and duration of disease stabilization in patients treated with these regimens. III. Determine the safety profile of these regimens in these patients. PROTOCOL 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 (1 vs 2 or more), and LDH value (up to 1.5 times upper limit of normal (ULN) vs greater than 1.5 times ULN). Patients are randomized to one of three treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on days 1 and 2. Arm II: Patients receive oxaliplatin IV over 2 hours on day 1. Arm III: Patients receive oxaliplatin IV concurrently with leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on day 1. Leucovorin calcium and fluorouracil are administered alone on day 2 on the same schedule as on day 1. Treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed for 30 days, every 2 weeks for up to 3 months, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 786 patients (262 per arm) will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum that is not amenable to potentially curative therapy (e.g., inoperable metastatic disease) - At least 1 unidimensionally measurable lesion at least 20 mm in diameter by conventional CT or MRI scan or at least 10 mm in diameter by spiral CT scan - Progressive disease by CT or MRI scan during or no more than 6 months after the last dose of prior first-line irinotecan, fluorouracil, and leucovorin calcium (Saltz regimen) for metastatic disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; One and only 1 prior chemotherapy regimen for metastatic disease consisting of first-line irinotecan, fluorouracil, and leucovorin calcium (Saltz regimen); Prior adjuvant fluorouracil with leucovorin calcium allowed; At least 3 weeks since prior chemotherapy for metastatic disease and recovered; No prior adjuvant irinotecan; No prior oxaliplatin - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy to study lesions unless evidence of progressive disease within the radiotherapy port; At least 3 weeks since prior radiotherapy - Surgery: See Disease Characteristics; At least 4 weeks since prior major surgery and recovered; Prior surgical resection of primary tumor or metastases allowed - Other: At least 30 days since prior investigational drugs; No other concurrent investigational agents; No other concurrent anti-cancer therapy; No concurrent participation in other investigational trials --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); AST and ALT 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 3 times ULN if liver metastases present) - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: No uncontrolled high blood pressure; No unstable angina, symptomatic congestive heart failure, or serious cardiac arrhythmia; No New York Heart Association class III or IV heart disease; No history of cardiac toxicities with prior fluorouracil and leucovorin calcium; No myocardial infarction within the past 6 months - Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 6 months after study; No known dihydropyrimidine dehydrogenase deficiency No allergy to platinum-containing drugs; No history of intolerance to study anti-emetics (e.g., 5-HT3 antagonists); No known peripheral neuropathy (absence of deep tendon reflexes as sole deficiency allowed); No uncontrolled diabetes; No active infection; No other active malignancy originating from primary site other than colon or rectum
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaceRothenberg, Study Chair, Sanofi-Synthelabo
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70821-2511
United States
Ivinson Memorial Hospital
Laramie, Wyoming, 82070
United States
Cooper Hospital/University Medical Center
Voorhees, New Jersey, 08043
United States
Piedmont Hematology-Oncology Associates-Triad
Winston Salem, North Carolina, 27103
United States
Missouri Cancer Care, P.C.
St. Charles, Missouri, 63301
United States
Offices of Richard Shapiro, Benjamin Stafford, and Sharon J. Yee
Arcadia, California, 91007-7678
United States
Florida Cancer Specialists
Ft. Myers, Florida, 33901
United States
Missouri Baptist Cancer Center
St. Louis, Missouri, 63131
United States
Kaiser Permanente - Denver
Denver, Colorado, 80205
United States
Northwestern Connecticut Oncology-Hematology Associates
Torrington, Connecticut, 06790
United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
United States
Interlakes Oncology/Hematology PC
Rochester, New York, 14623
United States
Cancer Care Center
New Albany, Indiana, 47150
United States
St. Thomas Medical Center
Nashville, Tennessee, 37205
United States
Louisiana State University School of Medicine
New Orleans, Louisiana, 70112-2822
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Midwest Oncology Consortium
Kansas City, Missouri, 64111
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Florida Community Cancer Center
Hudson, Florida, 34667
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Dayton Oncology/Hematology P.A.
Dayton, Ohio, 45439
United States
Dreyer Medical Clinic
Aurora, Illinois, 60506
United States
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Canada
St. John's Mercy Medical Center
St. Louis, Missouri, 63141
United States
University of Alberta
Edmonton, Alberta, T6G 2R7
Canada
Regional Hematology Oncology Associates
Durham, North Carolina, 27704
United States
North Florida Hematology & Oncology Associates
Jacksonville, Florida, 32204
United States
Parker Hughes Cancer Center
Roseville, Minnesota, 55113
United States
Oncology & Hematology Associates of West Broward
Tamarac, Florida, 33321
United States
Advanced Health Care
Milwaukee, Wisconsin, 53209
United States
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh, North Carolina, 27609
United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, 60035
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Capitol District Hematology Oncology Associates, P.C.
Latham, New York, 12110-0610
United States
Louisiana Oncology Associates
Lafayette, Louisiana, 70506
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Rocky Mountain Cancer Center
Denver, Colorado, 80218
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Naz Medical Center
Midwest City, Oklahoma, 73310
United States
Virginia Mason Medical Center
Seattle, Washington, 98111
United States
Oncology and Hematology Associates
Greenfield, Indiana, 46140
United States
Office of Ron D. Schiff
Tampa, Florida, 33613
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
Notre Dame Hospital
Montreal, Quebec, H4L 2M1
Canada
Hematology-Oncology Associates, PA
Pensacola, Florida, 32501
United States
Hematology/Oncology Associates
Port Saint Lucie, Florida, 34952
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Center for Oncology Research and Treatment, Medical City Hospital
Dallas, Texas, 75230
United States
Swedish Medical Center
Seattle, Washington, 98122-4307
United States
San Antonio Tumor and Blood Clinic
San Antonio, Texas, 78217
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Arkansas Oncology Associates, P.A.
Little Rock, Arkansas, 72207
United States
Texas Oncology, P.A.
Ft. Worth, Texas, 76104
United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214
United States
Baptist Health System Cancer Program
San Antonio, Texas, 78205
United States
Oncology-Hematology Group of South Florida
Miami, Florida, 33176
United States
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Canada
Oncology Associates of Cedar Rapids
Cedar Rapids, Iowa, 52403
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, 33428
United States
Hematology & Oncology Associates of Virginia
Richmond, Virginia, 23226
United States
Ocala Oncology Center
Ocala, Florida, 34474
United States
Cancer Care Northwest
Spokane, Washington, 99202
United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
United States
Hematology Oncology Consultants Inc
Columbus, Ohio, 43235
United States
Oncology Center at Providence Park
Mobile, Alabama, 36608
United States
Erlanger Health Systems
Chattanooga, Tennessee, 37403
United States
Medical Oncology Care Associates
Orange, California, 92668
United States
Northwest Cancer Specialists
Vancouver, Washington, 98664
United States
Hematology-Oncology Associates of Frederiksburg, Inc.
Fredericksburg, Virginia, 22401
United States
Missouri Cancer Associates
Columbia, Missouri, 65201
United States
Texas Cancer Center Southwest
Dallas, Texas, 75235
United States
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6
Canada
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Lakeland Regional Medical Center
Lakeland, Florida, 33804
United States
Office of Barry S. Berman
Orlando, Florida, 32806
United States
Bay Area Tumor Institute
Oakland, California, 94609
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Virginia Oncology Associates - Newport News
Newport News, Virginia, 23606
United States
Oncology/Hematology Associates - Beaver
Beaver, Pennsylvania, 15009
United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
United States
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, G5L 5T1
Canada
Lone Star Oncology
Austin, Texas, 78759
United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, 94589
United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
United States
Belleville General Hospital
Belleville, Ontario, K8N 5K5
Canada
Texas Oncology P.A.
Dallas, Texas, 75230-2503
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Physicians Office
Metairie, Louisiana, 70006
United States
Columbia Comprehensive Cancer Care Clinic
Columbia, Missouri, 65201
United States
St. Vincents Comprehensive Cancer Center
New York City, New York, 10011
United States
Cancer and Blood Institute of the Desert
Rancho Mirage, California, 92270
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611
United States
Center for Hematology-Oncology
Boca Raton, Florida, 33486
United States
Hematology and Oncology Consultants
Titusville, Florida, 32796
United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401-8122
United States
California Cancer Care, Inc.
Greenbrae, California, 94904
United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804
United States
West Clinic, P.C.
Memphis, Tennessee, 38117
United States
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, 11733
United States
South Texas Regional Cancer Centers - McAllen
McAllen, Texas, 78503
United States
Tyler Cancer Center
Tyler, Texas, 75702
United States
UW Cancer Center Wausau Hospital
Wausau, Wisconsin, 54401
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Memorial Hospital West
Pembroke Pines, Florida, 33028
United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
United States
Arizona Clinical Research Center
Tucson, Arizona, 85712
United States
Texas Oncology, P.A.
Garland, Texas, 75042
United States
Cancer Care Associates
Tulsa, Oklahoma, 74136
United States
Medical Oncology Internal Medicine
Los Angeles, California, 90067
United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074
United States
Office of Thomas A. Marsland
Orange Park, Florida, 32073
United States
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140
United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, 37901
United States
Memphis Cancer Center
Memphis, Tennessee, 38119
United States
P.M.K. Medical Group, Inc.
Oxnard, California, 93030
United States
Hematology/Oncology Associates
Jacksonville, Florida, 32216
United States
Park Nicollet Clinic
St. Louis Park, Minnesota, 55416
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Texas Oncology - Mesquite
Mesqutie, Texas, 75150
United States
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, 19107
United States
New York Medical College
Valhalla, New York, 10595
United States
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Canada
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, 35801
United States
University of Florida Health Science Center
Gainesville, Florida, 32610-0296
United States
Texas Oncology PA (TOPA) at Baylor-Sammons
Dallas, Texas, 75246
United States
Additional Information:
Study ID Numbers: CDR0000068394; SANOFI-EFC4584,BRCC-00036
Study Start Date: October 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008281
Other Recurrent Rectal Cancer Studies:
1. Cryosurgery in Treating Patients With Unresectable Liver Metastases from Colorectal Cancer
2. Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
3. SU011248 in Treating Patients With Metastatic Colorectal Adenocarcinoma (Cancer) That Has Not Responded to Previous Treatment With Irinotecan, Oxaliplatin, and a Fluoropyrimidine With or Without Bevacizumab
4. Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
5. Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer
Related Studies:
Other recurrent rectal cancer Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Comparison of Three Chemotherapy Regimens in Treating Patients with Metastatic Colorectal Cancer
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