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.
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.
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
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There are 74 Locations for this study
Tucson Arizona, 85712, United States
Pine Bluff Arkansas, 71603, United States
Covina California, 92807, United States
Duarte California, 91010, United States
Greenbrae California, 94904, United States
Los Angeles California, 90048, United States
Los Angeles California, 90057, United States
Palm Springs California, 92262, United States
San Diego California, 92120, United States
Vallejo California, 94589, United States
Walnut Creek California, 94598, United States
Denver Colorado, 80218, United States
Torrington Connecticut, 06790, United States
Washington District of Columbia, 20007, United States
Boca Raton Florida, 33486, United States
Daytona Beach Florida, 32114, United States
Fort Myers Florida, 33901, United States
Jacksonville Florida, 32216, United States
Leesburg Florida, 34748, United States
Miami Florida, 33176, United States
Orlando Florida, 32804, United States
Port Saint Lucie Florida, 34952, United States
Arlington Heights Illinois, 60004, United States
Aurora Illinois, 60506, United States
Chicago Illinois, 60611, United States
Decatur Illinois, 62526, United States
Terre Haute Indiana, 47809, United States
Des Moines Iowa, 50309, United States
Mason City Iowa, 50401, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
Baton Rouge Louisiana, 70821, United States
Metairie Louisiana, 70006, United States
Lowell Massachusetts, 01852, United States
Ann Arbor Michigan, 48106, United States
Gulfport Mississippi, 39501, United States
Jackson Mississippi, 39202, United States
Saint Joseph Missouri, 64506, United States
Billings Montana, 59107, United States
Long Branch New Jersey, 07740, United States
Neptune New Jersey, 07753, United States
New Brunswick New Jersey, 08901, United States
Ridgewood New Jersey, 07450, United States
West Long Branch New Jersey, 07764, United States
Albuquerque New Mexico, 87131, United States
Bronx New York, 10461, United States
Brooklyn New York, 11235, United States
East Setauket New York, 11733, United States
Malone New York, 12953, United States
New York New York, 10016, United States
New York New York, 10021, United States
Rochester New York, 14623, United States
Rochester New York, 14642, United States
Rockville Centre New York, 11570, United States
Valhalla New York, 10595, United States
Columbus Ohio, 43213, United States
Columbus Ohio, 43235, United States
Wooster Ohio, 44691, United States
Tulsa Oklahoma, 74104, United States
Bend Oregon, 97701, United States
Salem Oregon, 97309, United States
Bethlehem Pennsylvania, 18015, United States
Philadelphia Pennsylvania, 19107, United States
Providence Rhode Island, 02906, United States
Chattanooga Tennessee, 37404, United States
Collierville Tennessee, 38017, United States
Knoxville Tennessee, 37920, United States
Memphis Tennessee, 38120, United States
Dallas Texas, 75230, United States
San Antonio Texas, 78229, United States
Temple Texas, 76508, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84124, United States
Seattle Washington, 98109, United States
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