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Brief Title: Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
Official Title: Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer
Study ID: NCT00075595
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.
Detailed Description: OBJECTIVES: Primary * Determine the time to progression and time to death from progression in patients with recurrent or refractory metastatic unresectable colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan. Secondary * Determine the objective response and stabilization rate in patients treated with this regimen. * Determine the time to treatment failure in patients treated with this regimen. * Determine the duration of response in patients treated with this regimen. * Determine overall survival rate in patients treated with this regimen. * Determine the incidence of grade 3 or 4 toxicity in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive leucovorin calcium IV over 2 hours on day 1, irinotecan IV over 1 hour on days 1 and 3, and fluorouracil IV continuously over 46 hours beginning on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 18 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hopital Drevon, Dijon, , France
Centre Hospital Universitaire Hop Huriez, Lille, , France
Clinique Saint Jean, Lyon, , France
Hopital Saint Joseph, Marseille, , France
Intercommunal Hospital, Montfermeil, , France
American Hospital of Paris, Neuilly Sur Seine, , France
Hopital Europeen Georges Pompidou, Paris, , France
Hopital Bichat - Claude Bernard, Paris, , France
Hopital Saint Antoine, Paris, , France
Hopital Tenon, Paris, , France
Clinique Ste - Marie, Pontoise, , France
Polyclinique De Courlancy, Reims, , France
Clinique Armoricaine De Radiologie, Saint Brieuc, , France
Clinique de l'Orangerie, Strasbourg, , France
Centre Medico-Chirurgical Foch, Suresnes, , France
Name: May Mabro, MD
Affiliation: Hopital Foch
Role: