Colon Cancer Clinical Trial

Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer

Summary

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.

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Full Description

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.

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.

View Eligibility Criteria

Eligibility 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 scan or MRI) after 2 prior chemotherapy regimens for metastatic/recurrent disease At least 1 unidimensionally measurable lesion At least 20 mm by conventional CT scan or MRI 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

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

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

Study is for people with:

Colon Cancer

Phase:

Phase 2

Study ID:

NCT00016198

Recruitment Status:

Completed

Sponsor:

Prologue Research International

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There are 74 Locations for this study

See Locations Near You

Arizona Clinical Research Center
Tucson Arizona, 85712, United States
Arkansas Cancer Clinic, P.A.
Pine Bluff Arkansas, 71603, United States
Citrus Valley Medical Center
Covina California, 92807, United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte California, 91010, United States
California Cancer Care, Inc.
Greenbrae California, 94904, United States
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
Kenmar Research Institute
Los Angeles California, 90057, United States
Comprehensive Cancer Centers of the Desert
Palm Springs California, 92262, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego California, 92120, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo California, 94589, United States
John Muir Medical Center
Walnut Creek California, 94598, United States
Rocky Mountain Cancer Center
Denver Colorado, 80218, United States
Northwestern Connecticut Oncology-Hematology Associates
Torrington Connecticut, 06790, United States
Lombardi Cancer Center
Washington District of Columbia, 20007, United States
Center for Hematology-Oncology
Boca Raton Florida, 33486, United States
Halifax Medical Center
Daytona Beach Florida, 32114, United States
Florida Cancer Specialists
Fort Myers Florida, 33901, United States
Hematology/Oncology Associates
Jacksonville Florida, 32216, United States
Lake Heart and Cancer Medical Center
Leesburg Florida, 34748, United States
Oncology-Hematology Group of South Florida
Miami Florida, 33176, United States
Florida Hospital Cancer Institute
Orlando Florida, 32804, United States
Hematology/Oncology Associates
Port Saint Lucie Florida, 34952, United States
Northwest Medical Specialists, P.C.
Arlington Heights Illinois, 60004, United States
Dreyer Medical Clinic
Aurora Illinois, 60506, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago Illinois, 60611, United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur Illinois, 62526, United States
Hope Center
Terre Haute Indiana, 47809, United States
Medical Oncology and Hematology Associates
Des Moines Iowa, 50309, United States
Mercy Cancer Center
Mason City Iowa, 50401, United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington Kentucky, 40536, United States
James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
Baton Rouge General Medical Center
Baton Rouge Louisiana, 70821, United States
Cancer and Blood Institute
Metairie Louisiana, 70006, United States
Saints Memorial Medical Center
Lowell Massachusetts, 01852, United States
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
Medical Oncology Group
Gulfport Mississippi, 39501, United States
Jackson Oncology Associates, PLLC
Jackson Mississippi, 39202, United States
St. Joseph Oncology, Inc.
Saint Joseph Missouri, 64506, United States
Deaconess Billings Clinic
Billings Montana, 59107, United States
Monmouth Medical Center
Long Branch New Jersey, 07740, United States
Jersey Shore Cancer Center
Neptune New Jersey, 07753, United States
Central Jersey Oncology Center
New Brunswick New Jersey, 08901, United States
Hematology Associates of New Jersey, P.A.
Ridgewood New Jersey, 07450, United States
Monmouth Hematology-Oncology Associates, P.A.
West Long Branch New Jersey, 07764, United States
University of New Mexico Cancer Research & Treatment Center
Albuquerque New Mexico, 87131, United States
Albert Einstein Comprehensive Cancer Center
Bronx New York, 10461, United States
HemOnCare, P.C.
Brooklyn New York, 11235, United States
North Shore Hematology/Oncology Associates, P.C.
East Setauket New York, 11733, United States
Reddy Cancer Treatment Center
Malone New York, 12953, United States
New York University Medical Center
New York New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
Interlakes Oncology/Hematology PC
Rochester New York, 14623, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
South Shore Hematology Oncology Associates, P.C.
Rockville Centre New York, 11570, United States
New York Medical College
Valhalla New York, 10595, United States
Mid-Ohio Oncology/Hematology, Inc.
Columbus Ohio, 43213, United States
Hematology Oncology Consultants Inc
Columbus Ohio, 43235, United States
Lawrence M. Stallings Medical Practice
Wooster Ohio, 44691, United States
Oklahoma Oncology Inc.
Tulsa Oklahoma, 74104, United States
Bend Memorial Clinic
Bend Oregon, 97701, United States
Salem Hospital Regional Cancer Center
Salem Oregon, 97309, United States
Oncology Hematology of Lehigh Valley, P.C.
Bethlehem Pennsylvania, 18015, United States
Pennsylvania Oncology Hematology Associates
Philadelphia Pennsylvania, 19107, United States
Lifespan: The Miriam Hospital
Providence Rhode Island, 02906, United States
Memorial Hospital Cancer Center - Chattanooga
Chattanooga Tennessee, 37404, United States
Family Cancer Center
Collierville Tennessee, 38017, United States
Baptist Regional Cancer Center
Knoxville Tennessee, 37920, United States
West Cancer Clinic
Memphis Tennessee, 38120, United States
Center for Oncology Research and Treatment, Medical City Hospital
Dallas Texas, 75230, United States
Cancer Therapy and Research Center
San Antonio Texas, 78229, United States
Scott and White Memorial Hospital
Temple Texas, 76508, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City Utah, 84124, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Study ID:

NCT00016198

Recruitment Status:

Completed

Sponsor:


Prologue Research International

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