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Erbitux Study of CPT11, Oxaliplatin, UFToral Targeted Therapy (eSCOUT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01225744
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : June 11, 2014
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Suzanne Rowland, The Christie NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE October 20, 2010
First Posted Date  ICMJE October 21, 2010
Last Update Posted Date June 11, 2014
Study Start Date  ICMJE April 2009
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01225744 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2010)
  • Progression Free Survival [ Time Frame: 8 week intervals post starting treatment ]
    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 ]
    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 ]
    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 ]
  • Time to progression (TTP) [ Time Frame: 8 weekly intervals following starting treatment ]
    This is defined as the time from start of treatment to the time of documented radiological progression of disease locally
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Erbitux Study of CPT11, Oxaliplatin, UFToral Targeted Therapy
Official Title  ICMJE 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
Brief 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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: Cetuximab

    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: Erbitux
  • Drug: 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: Camptosar
  • Drug: 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: Eloxatin
  • Drug: 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.
    Other Names:
    • Tegafur
    • Uracil
Study Arms  ICMJE Experimental: Cetuximab plus Irinotecan, Oxaliplatin and UFT
Cetuximab plus Irinotecan, Oxaliplatin, UFToral
  • Drug: Cetuximab
  • Drug: Irinotecan
  • Drug: Oxaliplatin
  • Drug: UFT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2013)
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2010)
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01225744
Other Study ID Numbers  ICMJE 07_DOG03_133
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Suzanne Rowland, The Christie NHS Foundation Trust
Study Sponsor  ICMJE The Christie NHS Foundation Trust
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Mark Saunders Christie NHS Foundation Trust
PRS Account The Christie NHS Foundation Trust
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP