Phase III Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFOXIRI) Compared With Infusional Fluorouracil, Leucovorin and Irinotecan (FOLFIRI) as First-line Treatment for Metastatic Colorectal Cancer
18 Years
75 Years
Both
Metastatic Colorectal Cancer
Trial Information
Phase III Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFOXIRI) Compared With Infusional Fluorouracil, Leucovorin and Irinotecan (FOLFIRI) as First-line Treatment for Metastatic Colorectal Cancer
Survival of patients with metastatic colorectal cancer is correlated with the proportion of
patients who receive all the three active drugs in the course of the disease, but not with
the proportion of patients who receive any second-line therapy. In a sequential strategy,
not all patients who progress after first-line chemotherapy are able to receive second-line
treatment. Moreover, there is a correlation between the response rate to chemotherapy and
the postchemotherapy radical resection rate of metastases.
Therefore, a way to improve the outcome of metastatic colorectal cancer patients could be to
administer a first-line regimen containing the three active agents.
Inclusion Criteria:
- adenocarcinoma of the colon or rectum
- unresectable metastatic disease
- age 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower if age 70
years or younger or ECOG performance status of 0 if age 71 to 75 years measurable
disease according to WHOcriteria
- leukocyte count of at least 3,500/mm3, neutrophils count of at least 1,500/mm3,
platelet count of at least 100,000/mm3
- serum creatinine of 1.3 mg/dL or less
- serum bilirubin less than 1.5 mg/dL and AST, ALT, and alkaline phosphatase 2.5 x
normal values or less (
- previous fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than
6 months before random assignment
Exclusion Criteria:
- previous palliative chemotherapy for metastatic disease
- previous chemotherapy including irinotecan or oxaliplatin
- symptomatic cardiac disease, myocardial infarction in the last 24 months or
uncontrolled arrhythmia
- active infections
- inflammatory bowel disease
- total colectomy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate (RR)
Outcome Description:
Responses are evaluated every 8 weeks according to WHO criteria. The determination of responses and progression was initially based on investigator-reported measurements; computed tomography scans of all responding patients and of patients with stable disease were subsequently subjected to external review by an independent panel.
Outcome Time Frame:
Responses are evaluated every 8 weeks according to WHO criteria and reviewed by an independent panel at the end of treatment (6 months)
Safety Issue:
No
Principal Investigator
Alfredo Falcone, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Pisa
Authority:
Italy: The Italian Medicines Agency
Study ID:
ASL601LIOM03
NCT ID:
NCT01219920
Start Date:
November 2001
Completion Date:
November 2009
Related Keywords:
- Metastatic Colorectal Cancer
- Metastatic colorectal cancer
- Phase III
- FOLFOXIRI
- FOLFIRI
- Colorectal Neoplasms
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