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Spots Global Cancer Trial Database for Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: May Mabro, MD

Affiliation: Hopital Foch

Role:

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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