Neoplasms

Digestive System Diseases

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Rare Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Oculocerebral Syndrome With Hypopigmentation

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Cetuximab

Afatinib

Antineoplastic Agents, Immunological

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Afatinib 40 mg daily Cetuximab 500 mg/m2 every 2 weeks until progression

Cetuximab 500mg/m2 every 2 weeks until progression After progression: Cetuximab 500mg/m2 + Afatinib 40 mg per day until progression

Afatinib taken orally, cetuximab administered intravenously

Cetuximab + Afatinib

Helene SENELLART, Dr

Evelyne BOUCHER, Dr

Eric FRANCOIS, Dr

Emmanuelle SAMALIN SCALZI, Dr

Meher BEN ABDELGHANI, Dr

Antoine ADENIS, Pr

Christelle DE LA FOUCHARDIERE, Dr

François GHIRENGHELLI, Dr

Olivier DUBROEUCQ, Dr

Emmanuelle MITRY, Dr

Christophe BORG, Pr

Yves BOUCARN, Dr

Marion CHAUVENET, Dr

This is a multicentric, phase II and open label study.75 patients are expected to be randomized in 35 centers. The main objective is to assess the efficacy and safety of Afatinib -cetuximab combo versus cetuximab alone in treatment of patients with refractory wtKRAS metastatic colorectal cancer.

Patients who will sign the inform consent will be enrolled into one of two groups. Group A will receive Afatinib ( 40mg per day) and Cetuximab (500mg/m2)every two weeks until progression. Group B will receive Cetuximab (500mg/m2) alone every two weeks until progression and after progression,patients from group B will receive afatinib (group A treatment) until progression. The criteria for evaluation will be tumor response and progression documented by CT scan and according to RECIST criteria version 1.1.

Patient will also sign a inform consent before participating in biological study. The aim of this translational study is to collect tumor and blood sample in order to determine, the biological factors which are predictive of the response to treatment.

Dual Targeting of EGFR With Cetuximab and Afatinib to Treat Refractory wtKRAS Metastatic Colorectal Cancer

A Multicentric Randomized Phase II Trial Evaluating Dual Targeting of EGFR Using the Combination of Cetuximab and Afatinib Versus Cetuximab Alone in Patients With Chemotherapy Refractory wtKRAS Metastatic Colorectal Cancer

The progression rate is defined as percentage of patients without progression at 6 months after observation of all patients at 6 months

Overall response rate is defined as percentage of subjects with a confirmed complete or partial response as per RECIST V1.1 criteria

It is define as the time of from randomization to date of first documented progression or any cause of death

Overall and specific survival is defined from time of randomization to the date of documented death

EORTC QLQ-C30 and QLQ-CR29 are questionnaires developed to assess the quality of life of cancer patients

Safety of the study treatment will be assessed on occurrence of Adverse Events (AEs)

Spots Global Cancer Trial Database for cetuximab + afatinib