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

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Cetuximab
Irinotecan
Oxaliplatin
UFT
Sponsored by
The Christie NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North Wales Cancer Treatment Centre
  • The Royal Marsden
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cetuximab plus Irinotecan, Oxaliplatin and UFT

Arm Description

Cetuximab plus Irinotecan, Oxaliplatin, UFToral

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Resectability of liver, lung and pelvic disease after chemotherapy
Time to progression (TTP)
This is defined as the time from start of treatment to the time of documented radiological progression of disease locally

Full Information

First Posted
October 20, 2010
Last Updated
June 10, 2014
Sponsor
The Christie NHS Foundation Trust
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01225744
Brief Title
Erbitux Study of CPT11, Oxaliplatin, UFToral Targeted Therapy
Acronym
eSCOUT
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Christie NHS Foundation Trust
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cetuximab plus Irinotecan, Oxaliplatin and UFT
Arm Type
Experimental
Arm Description
Cetuximab plus Irinotecan, Oxaliplatin, UFToral
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
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 .
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
Camptosar
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
UFT
Other Intervention Name(s)
Tegafur, Uracil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rate (according to RECIST criteria)
Description
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.
Time Frame
8 weeks post starting treatment
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
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.
Time Frame
8 week intervals post starting treatment
Title
Overall survival (OS; all causes of death).
Description
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.
Time Frame
3 years post treatment
Title
Toxicity
Description
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.
Time Frame
2 months post starting treatment
Title
Resectability of liver, lung and pelvic disease after chemotherapy
Time Frame
8 weekly intervals from the start of treatment
Title
Time to progression (TTP)
Description
This is defined as the time from start of treatment to the time of documented radiological progression of disease locally
Time Frame
8 weekly intervals following starting treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Saunders
Organizational Affiliation
Christie NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Wales Cancer Treatment Centre
City
Llansantffraid Glan Conwy
ZIP/Postal Code
LL18 5UJ
Country
United Kingdom
Facility Name
The Royal Marsden
City
London and Surrey
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

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Erbitux Study of CPT11, Oxaliplatin, UFToral Targeted Therapy

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