Metastatic Colorectal CancerPhase 2eSCOUTNCT01225744
Erbitux Study of CPT11, Oxaliplatin, UFToral Targeted Therapy
A Phase 2 study testing Cetuximab, Irinotecan and Oxaliplatin in people with Metastatic Colorectal Cancer, run by The Christie NHS Foundation Trust at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Cetuximab, Irinotecan and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Apr 2009to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the colon or rectum.
- Patients must not have a mutation of K-ras
- Inoperable metastatic or locoregional disease (synchronous or recurrence)
- No previous chemotherapy for established metastatic disease (adjuvant chemotherapy must have been completed more than 6 months prior to trial entry)
- Measurable or evaluable disease
- Bone marrow function: neutrophil count >1.5 x109/l and platelet count >150 x109/l
Show all 13Show fewer
- Hepatobiliary function: serum bilirubin <1.5 x upper limit of normal (ULN); ALP <5 x ULN; transaminase (AST or ALT) <3 x ULN.(≤ 5 if liver mets are present)
- Renal function: estimated creatinine clearance >50 ml/min, or measured Glomerular filtration rate (GFR) (EDTA or creatinine clearance) in normal range
- ECOG performance status 0-1 and considered fit and able to undergo all possible treatments
- For women of child-bearing potential a negative pregnancy test is required and adequate contraceptive precautions such as a sheath for their partner must be used
- For men - adequate contraception such as a sheath must be used
- Patients must give written, informed consent
- Life expectancy ≥ 3 months.
Who cannot join
- Patients that have a K-ras mutation
- Concurrent uncontrolled medical illness, or other previous or current malignant disease likely to interfere with protocol treatments or comparisons
- Partial or complete bowel obstruction
- Prior EGFR antibody therapy
- Age <18
- Chronic diarrhoea or inflammatory bowel disease
Show all 20Show fewer
- Known Pyruvate Dehydrogenase Phosphatase (DPD) deficiency
- Gilbert's syndrome or other congenital abnormality of biliary transport
- Previous transplant surgery, requiring immunosuppressive therapy
- Regular / uncontrolled angina or cardiac arrhythmias
- Clinically relevant coronary artery disease. History of Myocardial infarction in the last 12 months
- Previous investigational agent in the last 4 weeks
- Metastatic disease to brain
- Any pregnant or lactating women
- Patients receiving therapy with haloginated antiviral drugs (eg: sorivudine)
- Patients who have experienced life-threatening toxicities with fluoropyrimidines treatment
- Patients suffering from any condition that may affect the absorption of UFT or folinic acid.
- Patients with known deficiency of or are on inhibitors of cytochrome P450 2A6
- Patients who have previously had radiotherapy to the abdomen or pelvis in the last 6 months
- Any medical or psychological condition that in the opinion of the investigator would not enable the patient to complete the study or knowingly give informed consent
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
North Wales Cancer Treatment Centre
Llansantffraid Glan Conwy, LL18 5UJ
The Royal Marsden
London and Surrey
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
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).
Read more
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
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Cetuximab, Irinotecan, Oxaliplatin, UFT
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
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 .
IrinotecanDrug
Also called Camptosar
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.
OxaliplatinDrug
Also called Eloxatin
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.
UFTDrug
Also called Tegafur, Uracil
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.
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab plus Irinotecan, Oxaliplatin and UFT | Experimental | Cetuximab plus Irinotecan, Oxaliplatin, UFToral Receives: Drug: Cetuximab; Drug: Irinotecan; Drug: Oxaliplatin; Drug: UFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (according to RECIST criteria)
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.
Measured: 8 weeks post starting treatment
Secondary outcomes (5)
Progression Free Survival
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.
Measured: 8 week intervals post starting treatment
Overall survival (OS; all causes of death).
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.
Measured: 3 years post treatment
Toxicity
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.
Measured: 2 months post starting treatment
Resectability of liver, lung and pelvic disease after chemotherapy
Measured: 8 weekly intervals from the start of treatment
Time to progression (TTP)
This is defined as the time from start of treatment to the time of documented radiological progression of disease locally
Measured: 8 weekly intervals following starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startApr 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Mark Saunders, Principal investigator, Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225744
- Sponsor's protocol ID
- 07_DOG03_133
- Acronym
- eSCOUT
- Status last verified
- Jun 2014
- First submitted
- 20 Oct 2010
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01225744
- Acronym / sponsor ID
- eSCOUT / 07_DOG03_133
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab plus Irinotecan, Oxaliplatin and UFT | Experimental | Drug: Cetuximab, Drug: Irinotecan, Drug: Oxaliplatin, Drug: UFTCetuximab plus Irinotecan, Oxaliplatin, UFToral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed adenocarcinoma of the colon or rectum.
- Patients must not have a mutation of K-ras
- Inoperable metastatic or locoregional disease (synchronous or recurrence)
- No previous chemotherapy for established metastatic disease (adjuvant chemotherapy must have been completed more than 6 months prior to trial entry)
- Measurable or evaluable disease
Key exclusion criteria (20 listed)
- Patients that have a K-ras mutation
- Concurrent uncontrolled medical illness, or other previous or current malignant disease likely to interfere with protocol treatments or comparisons
- Partial or complete bowel obstruction
- Prior EGFR antibody therapy
- Age <18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabAlso: ErbituxCetuximab 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 . | Drug | Cetuximab plus Irinotecan, Oxaliplatin and UFT |
| IrinotecanAlso: CamptosarDose 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. | Drug | Cetuximab plus Irinotecan, Oxaliplatin and UFT |
| OxaliplatinAlso: EloxatinDose 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. | Drug | Cetuximab plus Irinotecan, Oxaliplatin and UFT |
| UFTAlso: Tegafur, UracilUFT 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. | Drug | Cetuximab plus Irinotecan, Oxaliplatin and UFT |
Primary outcome
Objective response rate (according to RECIST criteria)
Time frame: 8 weeks post starting treatment
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.
5 secondary outcomes
Progression Free Survival
Time frame: 8 week intervals post starting treatment
Overall survival (OS; all causes of death).
Time frame: 3 years post treatment
Toxicity
Time frame: 2 months post starting treatment
Resectability of liver, lung and pelvic disease after chemotherapy
Time frame: 8 weekly intervals from the start of treatment
Time to progression (TTP)
Time frame: 8 weekly intervals following starting treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Related trials for Metastatic Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Saunders principal investigator
Christie NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab, Irinotecan and Oxaliplatin in people with Metastatic Colorectal Cancer, run by The Christie NHS Foundation Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (according to RECIST criteria) (time frame: 8 weeks post starting treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.