Metastatic Colorectal Cancer Clinical Trial
Official title:
A Phase II Study Evaluating the Use of Concurrent Cetuximab, Irinotecan, Oxaliplatin and UFT in the First Line Treatment of Patients With Metastatic Colorectal Cancer
A Phase II trial to demonstrate the response rate, using the Response evaluation criteria in
solid tumours (RECIST) criteria, of patients with locally advanced / metastatic colorectal
cancer treated with combination of irinotecan, oxaliplatin, UFT and cetuximab.
ENDPOINTS Primary: Objective response rate (RECIST) Secondary: Progression free survival
(PFS), Overall survival (OS) Toxicity (CTCAE), Resectability of liver, lung and pelvic
disease after chemotherapy, Time to progression (TTP).
POPULATION: The trial aims to recruit 50 patients with inoperable, metastatic colorectal
cancer ELIGIBILITY: Histologically confirmed colorectal adenocarcinoma Normal haematology
and adequate renal and liver function Written informed consent and able to attend follow-up
for at least 3 months TREATMENT 4 weekly cycles of chemotherapy with alternating irinotecan
(day 1) and oxaliplatin(day 15). Cetuximab every 2 weeks and oral UFT with Leucovorin for 3
weeks every 4 weeks.
DURATION First patient recruited April 2009. Accrual to take place over 24 months Follow-up
will continue until death or for a minimum of 3 years
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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