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Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer Clinical research trials and Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer healthcare trials occur in a lot of of places across 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 effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer. Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer  Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer
Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer
For Condition: stage 4 colon cancer,adenocarcinoma of the rectum,recurrent rectal cancer,adenocarcinoma of the colon,recurrent colon cancer,Stage 4 rectal cancer
Status: No longer recruiting
Sponsor(s): Prologue Research International ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combining fluorouracil and leucovorin with or without oxaliplatin in treating patients who have recurrent metastatic colorectal cancer.
Details: OBJECTIVES: I. Compare the overall response rate and overall survival of patients with recurrent metastatic colorectal adenocarcinoma treated with third-line therapy comprising fluorouracil and leucovorin calcium with or without oxaliplatin. II. Compare the onset and duration of complete and partial responses and duration of disease stabilization in patients treated with these regimens. III. Compare the proportion of patients with stable disease and proportion of patients with tumor-related symptomatic improvement treated with these regimens. IV. Compare the time to disease progression and time to tumor-related symptomatic worsening in patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on days 1 and 2. Arm II: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on day 1. On day 2, patients receive leucovorin calcium and fluorouracil as in arm I. Treatment in both arms repeats every 2 weeks for at least 1 year in the absence of disease progression. Patients are followed at day 30 and then for approximately 6 months. PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed adenocarcinoma of the colon or rectum; Metastatic/recurrent disease not amenable to potentially curative therapy (e.g., inoperable metastatic disease) - Documented sequential disease progression (by CT or MRI scan) after 2 prior chemotherapy regimens for metastatic/recurrent disease - At least 1 unidimensionally measurable lesion At least 20 mm by conventional CT or MRI scan OR At least 10 mm by spiral CT scan - Must have received prior fluorouracil (or capecitabine) and leucovorin calcium with or without irinotecan as first-line therapy and irinotecan with or without fluorouracil (or capecitabine) and leucovorin calcium as second-line therapy for metastatic disease --Prior/Concurrent Therapy-- - Biologic therapy: No prior anticancer biologic therapy - Chemotherapy: See Disease Characteristics; No prior oxaliplatin; No prior adjuvant irinotecan; Prior adjuvant fluorouracil and leucovorin calcium allowed; At least 3 weeks since prior chemotherapy (e.g., second-line irinotecan with or without fluorouracil (or capecitabine) and leucovorin calcium) for metastatic disease and recovered - Endocrine therapy: Not specified - Radiotherapy: At least 3 weeks since prior radiotherapy; No prior radiotherapy to target lesion unless documented progression within the radiation portal - Surgery: See Disease Characteristics; At least 4 weeks since prior surgery for primary tumor or metastases and recovered - Other: No prior investigational anticancer drug; No other concurrent investigational agents --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 and SGPT no greater than 2 times ULN (6 times ULN if documented liver metastases present); Alkaline phosphatase no greater than 2 times ULN (6 times ULN if documented liver metastases present) - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: No New York Heart Association class III or IV symptomatic congestive heart failure; No serious cardiac arrhythmia; No unstable angina; No myocardial infarction within the past 6 months - Pulmonary: No interstitial pneumonia; No 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 peripheral neuropathy (absence of deep tendon reflexes as the sole neurologic abnormality allowed); No diabetes or active infection; No known dihydropyrimidine dehydrogenase deficiency
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardGams, Study Chair, Prologue Research International
Memorial Hospital Cancer Center - Chattanooga
Chattanooga, Tennessee, 37404
United States
New York University Medical Center
New York City, New York, 10016
United States
Salem Hospital Regional Cancer Center
Salem, Oregon, 97309-5014
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
Hematology/Oncology Associates
Port Saint Lucie, Florida, 34952
United States
Lake Heart and Cancer Medical Center
Leesburg, Florida, 34748
United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
United States
Scott and White Memorial Hospital
Temple, Texas, 76508
United States
Hematology Associates of New Jersey, P.A.
Ridgewood, New Jersey, 07450
United States
Citrus Valley Medical Center
Covina, California, 92807
United States
Jersey Shore Cancer Center
Neptune, New Jersey, 07753
United States
Arkansas Cancer Clinic, P.A.
Pine Bluff, Arkansas, 71603
United States
Medical Oncology Group
Gulfport, Mississippi, 39501
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Hematology Oncology Consultants Inc
Columbus, Ohio, 43235
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Arizona Clinical Research Center
Tucson, Arizona, 85712
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Cancer and Blood Institute
Metairie, Louisiana, 70006
United States
Medical Oncology and Hematology Associates
Des Moines, Iowa, 50309
United States
Mercy Cancer Center
Mason City, Iowa, 50401
United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, 94589
United States
HemOnCare, P.C.
Brooklyn, New York, 11235
United States
South Shore Hematology Oncology Associates, P.C.
Rockville Centre, New York, 11570
United States
Kenmar Research Institute
Los Angeles, California, 90057
United States
Mid-Ohio Oncology/Hematology, Inc.
Columbus, Ohio, 43213
United States
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, 84124
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
Interlakes Oncology/Hematology PC
Rochester, New York, 14623
United States
Comprehensive Cancer Centers of the Desert
Palm Springs, California, 92262
United States
St. Joseph Oncology, Inc.
St. Joseph, Missouri, 64506
United States
Halifax Medical Center
Daytona Beach, Florida, 32114
United States
Monmouth Hematology-Oncology Associates, P.A.
West Long Branch, New Jersey, 07764
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Bend Memorial Clinic
Bend, Oregon, 97701
United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
United States
Hematology/Oncology Associates
Jacksonville, Florida, 32216
United States
Central Jersey Oncology Center
New Brunswick, New Jersey, 08901
United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
United States
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, 11733
United States
Oncology Hematology of Lehigh Valley, P.C.
Bethlehem, Pennsylvania, 18015
United States
Northwestern Connecticut Oncology-Hematology Associates
Torrington, Connecticut, 06790
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Family Cancer Center
Collierville, Tennessee, 38017
United States
Center for Hematology-Oncology
Boca Raton, Florida, 33486
United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804
United States
Baptist Regional Cancer Center
Knoxville, Tennessee, 37920
United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536-0093
United States
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202
United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218
United States
Cancer Therapy and Research Center
San Antonio, Texas, 78229
United States
Northwest Medical Specialists, P.C.
Arlington Heights, Illinois, 60004
United States
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, 87131
United States
New York Medical College
Valhalla, New York, 10595
United States
Center for Oncology Research and Treatment, Medical City Hospital
Dallas, Texas, 75230
United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, 19107
United States
Hope Center
Terre Haute, Indiana, 47809
United States
Oklahoma Oncology Inc.
Tulsa, Oklahoma, 74104
United States
West Cancer Clinic
Memphis, Tennessee, 38120
United States
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
United States
Lawrence M. Stallings Medical Practice
Wooster, Ohio, 44691
United States
Reddy Cancer Treatment Center
Malone, New York, 12953
United States
Oncology-Hematology Group of South Florida
Miami, Florida, 33176
United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
United States
Dreyer Medical Clinic
Aurora, Illinois, 60506
United States
Florida Cancer Specialists
Ft. Myers, Florida, 33901
United States
Deaconess Billings Clinic
Billings, Montana, 59107-5100
United States
Saints Memorial Medical Center
Lowell, Massachusetts, 01852
United States
John Muir Medical Center
Walnut Creek, California, 94598
United States
California Cancer Care, Inc.
Greenbrae, California, 94904
United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109
United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70821-2511
United States
Additional Information:
Study ID Numbers: CDR0000068606; SANOFI-EFC4760,PROLOGUE-EFC4760
Study Start Date: May 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016198
Other Stage 4 Colon Cancer Studies:
1. Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
2. Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
3. Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer
4. Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
5. Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Related Studies:
Other stage 4 colon cancer Clinical Trials
Other Florida Clinical Trials
Other Port Saint Lucie Clinical Trials
Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer
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