Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess feasibility of chemoembolization with DC Bead loaded with Irinotecan in combination with Cetuximab and 5FU/LV as a first line treatment for wildtype KRAS unresectable liver metastases from colorectal cancer.

Detailed Description
-----------------
20 patients will be included. The duration of the trial will be approximately 24 months. Every 8 weeks there will be a tumour lesion assessment.

Official Title
-----------------
Chemoembolisation With Irinotecan Loaded DC Bead (DEBIRI) in Combination With Cetuximab and 5FU/LV in the First Line Treatment of Patients With KRAS Wildtype Metastatic Colorectal Cancer (mCRC)

Conditions
-----------------
Liver Metastases, Colorectal Cancer

Intervention / Treatment
-----------------
* Device: DC Bead™
* Drug: Cetuximab
* Drug: 5 FU
* Drug: Irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of stage IV KRAS wild-type colorectal adenocarcinoma, with metastases predominantly in the liver (≥80% of tumor burden) that are deemed unresectable. Primary tumour has been treated with complete surgical resection without evidence of residual tumour Patients must have at least 1 measurable lesion (RECIST criteria) Performance status ECOG 0-1 Aged ≥18 years Life expectancy > 3 months No prior chemotherapy for metastatic disease Hematologic function: WBC ≥ 3.0 x 10*9/L, platelets ≥ 100 x10*9/L Adequate organ function as measured by: Serum creatinine £ 1.5 x upper limit of normal (ULN) Serum transaminases (AST & ALT) £ 5 x ULN Bilirubin> 1.5 times the upper limit of the normal range Women of child bearing potential and fertile men are required to use effective contraception (negative βHCG for women of child-bearing age) Signed, written informed consent Patients with patent main portal vein Maximum liver involvement ≤60% Exclusion Criteria: Presence of CNS metastases Contraindications to FU/LV, Irinotecan or Cetuximab Active bacterial, viral or fungal infection within 72 hours of study entry Women who are pregnant or breast feeding Allergy to contrast media or history of severe hypersensitivity to study drugs. Presence of another concurrent malignancy. Prior malignancy in the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix Any contraindication for hepatic embolization procedures: porto-systemic shunt hepatofugal blood flow severe atheromatosis Contraindication to hepatic artery catheterization, such as a patient with severe peripheral vascular disease precluding catheterization Other significant medical or surgical condition, or any medication or treatment regimens, that would place the patient at undue risk, that would preclude the safe use of chemoembolization or would interfere with study participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Chemoembolization<br>chemoembolization with DC Bead™ loaded with Irinotecan | Device: DC Bead™<br>* chemoembolization with DC Bead™ loaded with Irinotecan<br>* Other names: Irinotecan;Drug: Cetuximab<br>* 400 mg/m² IV at day 1 followed by 250 mg/m² IV weekly<br>* Other names: Erbitux;Drug: 5 FU<br>* every 2 weeks IV<br>* Other names: 5 fluoro uracyl;Drug: Irinotecan<br>* every 4 weeks chemoembolization<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of chemoembolization with DC Bead loaded with Irinotecan | Feasibility of the study by measuring the number of enrolled patients who can finish the first cycle of treatment | after one cycle = after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | progression-free survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chemoembolization, DC Bead™, Irinotecan, Cetuximab, 5FU/LV, KRAS, metastatic colorectal cancer