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

The Christie NHS Foundation Trust

Status and phase

Completed

Phase 2

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: Cetuximab

Drug: Oxaliplatin

Drug: UFT

Drug: Irinotecan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01225744

07_DOG03_133

Details and patient eligibility

About

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

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No 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