Clinical trial · Interventional
Erbitux Study of CPT11, Oxaliplatin, UFToral Targeted Therapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| UFT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cetuximab plus Irinotecan, Oxaliplatin and UFT
- description
- Cetuximab plus Irinotecan, Oxaliplatin, UFToral
- interventionNames
- Drug: Cetuximab
- Drug: Irinotecan
- Drug: Oxaliplatin
- Drug: UFT
Primary outcomes (1)
- measure
- Objective response rate (according to RECIST criteria)
- timeFrame
- 8 weeks post starting treatment
- 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.
Secondary outcomes (5)
- measure
- Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available