Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
Recruitment status was Active, not recruiting
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.
Drug: FOLFIRI regimen
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer|
- Time to progression [ Designated as safety issue: No ]
- Time to death from progression [ Designated as safety issue: No ]
- Objective response [ Designated as safety issue: No ]
- Stabilization rate [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Overall survival rate [ Designated as safety issue: No ]
- Incidence of grade 3 or 4 toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||June 2002|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075595
|Dijon, France, 21000|
|Centre Hospital Universitaire Hop Huriez|
|Lille, France, 59037|
|Clinique Saint Jean|
|Lyon, France, 69008|
|Hopital Saint Joseph|
|Marseille, France, 13008|
|Montfermeil, France, 93370|
|American Hospital of Paris|
|Neuilly Sur Seine, France, F-92202|
|Paris, France, 75970|
|Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Hopital Bichat - Claude Bernard|
|Paris, France, 75018|
|Clinique Ste - Marie|
|Pontoise, France, 95300|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|Clinique Armoricaine De Radiologie|
|Saint Brieuc, France, F-22015|
|Clinique de l'Orangerie|
|Strasbourg, France, 67010|
|Centre Medico-Chirurgical Foch|
|Suresnes, France, 92151|
|Investigator:||May Mabro, MD||Hopital Foch|