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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

Phase 2
18 Years
Open (Enrolling)
Metastatic Colorectal Cancer

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Trial Information

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

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

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (according to RECIST criteria)

Outcome 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.

Outcome Time Frame:

8 weeks post starting treatment

Safety Issue:


Principal Investigator

Mark Saunders

Investigator Role:

Principal Investigator

Investigator Affiliation:

Christie NHS Foundation Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

April 2009

Completion Date:

December 2013

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms