Erbitux Study of CPT11, Oxaliplatin, UFToral Targeted Therapy
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
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