Erbitux Study of CPT11, Oxaliplatin, UFToral Targeted Therapy (eSCOUT)
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
Metastatic Colorectal Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Objective response rate (according to RECIST criteria) [ Time Frame: 8 weeks post starting treatment ] [ Designated as safety issue: No ]Patients will receive triphasic CT scans at 8 weekly intervals after treatment has started. Patients remain on trial until disease progression or at the discretion of the Investigator.
- Progression Free Survival [ Time Frame: 8 week intervals post starting treatment ] [ Designated as safety issue: No ]Progression will be defined according to RECIST criteria with appropriate clinical assessment and radiological investigations. This will be measured from the time of entry into the study.
- Overall survival (OS; all causes of death). [ Time Frame: 3 years post treatment ] [ Designated as safety issue: No ]The date and cause of death will be recorded for each patient. Survival will be measured from the date of registration into the trial and will be reported on an intention-to treat-basis.
- Toxicity [ Time Frame: 2 months post starting treatment ] [ Designated as safety issue: Yes ]
Grade 3 or 4 Adverse Events experienced from the start of treatment up to the point of the first response CT scheduled for 8 weeks after treatment start date.
Number and description of Serious Adverse Events experienced will also be recorded.
- Resectability of liver, lung and pelvic disease after chemotherapy [ Time Frame: 8 weekly intervals from the start of treatment ] [ Designated as safety issue: No ]
- Time to progression (TTP) [ Time Frame: 8 weekly intervals following starting treatment ] [ Designated as safety issue: No ]This is defined as the time from start of treatment to the time of documented radiological progression of disease locally
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Cetuximab plus Irinotecan, Oxaliplatin and UFT
Cetuximab plus Irinotecan, Oxaliplatin, UFToral
Cetuximab will be prepared under Good Manufacturing practice (GMP) and supplied by Merck KGaA (Darmstadt, Germany) as a solution for intravenous infusion. It will be made up into 250ml with N/Saline.
Dose administered is 400mg/m2 and will be given on day 1 and day 15 of a 28 day cycle.Cetuximab will always be administered first, i.e. the cetuximab infusion should be completed one hour before any chemotherapy begins. The cetuximab dose must always be based on the body surface area(BSA). There is no restriction for cetuximab in patients with a BSA > 2 m2 .
Other Name: ErbituxDrug: Irinotecan
Dose is 180mg/m2 made up into 250ml with 5% dextrose or 0.9% saline. It will be administered as a short infusion over 60-90 minutes after a 60 minute gap left after cetuximab administration. Irinotecan is administered on day 1 of the 28 day cycle.
Other Name: CamptosarDrug: Oxaliplatin
Dose is 100mg/m2 and will be made up into 250ml with 5% dextrose. It will be administered as a short infusion over 120 minutes after the 60 minute gap left after cetuximab administration. Oxaliplatin is administered on day 15 of the 28 day cycle.
Other Name: EloxatinDrug: UFT
UFT dose is 250mg/m2 and is given in three divided doses with calcium folate 30mg p.o. tds on days 1-21 of the 28 day cycle. The highest dose of UFT should be given in the morning if the dose cannot be divided equally.
|North Wales Cancer Treatment Centre|
|Llansantffraid Glan Conwy, United Kingdom, LL18 5UJ|
|The Royal Marsden|
|London and Surrey, United Kingdom|
|The Christie NHS Foundation Trust|
|Manchester, United Kingdom, M20 4BX|
|Principal Investigator:||Mark Saunders||Christie NHS Foundation Trust|