Spots Global Cancer Trial Database for Dual Targeting of EGFR With Cetuximab and Afatinib to Treat Refractory wtKRAS Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Dual Targeting of EGFR With Cetuximab and Afatinib to Treat Refractory wtKRAS Metastatic Colorectal Cancer
Official Title: 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
Study ID: NCT01919879
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Institute de Cancérologie de la Loire, Nantes, , France
Contact Details
Name: Helene SENELLART, Dr
Affiliation: Centre René Gauducheau- Nantes Saint herbelain
Role: PRINCIPAL_INVESTIGATOR
Name: Evelyne BOUCHER, Dr
Affiliation: Centre Eugène Marquis-Rennes
Role: PRINCIPAL_INVESTIGATOR
Name: Eric FRANCOIS, Dr
Affiliation: Centre Antoine Lacassagne-Nice
Role: PRINCIPAL_INVESTIGATOR
Name: Emmanuelle SAMALIN SCALZI, Dr
Affiliation: Centre Val d'Aurel-Paul Lamarque-Montpellier
Role: PRINCIPAL_INVESTIGATOR
Name: Meher BEN ABDELGHANI, Dr
Affiliation: Centre Paul Strauss-Strasbourg
Role: PRINCIPAL_INVESTIGATOR
Name: Antoine ADENIS, Pr
Affiliation: Centre Oscar Lambret_Lille
Role: PRINCIPAL_INVESTIGATOR
Name: Christelle DE LA FOUCHARDIERE, Dr
Affiliation: Centre Léon Bérard-Lyon
Role: PRINCIPAL_INVESTIGATOR
Name: François GHIRENGHELLI, Dr
Affiliation: Centre Georges Leclerc-Dijon
Role: PRINCIPAL_INVESTIGATOR
Name: Olivier DUBROEUCQ, Dr
Affiliation: Centre Jean Godinot-Reims
Role: PRINCIPAL_INVESTIGATOR
Name: Emmanuelle MITRY, Dr
Affiliation: Hopital Rene Huguenin_Intitut Curie_Paris
Role: PRINCIPAL_INVESTIGATOR
Name: Christophe BORG, Pr
Affiliation: Hôpital Jean Minjoz-Besaçon
Role: PRINCIPAL_INVESTIGATOR
Name: Yves BOUCARN, Dr
Affiliation: Institut Bergonié Bordeaux
Role: PRINCIPAL_INVESTIGATOR
Name: Christophe BORG, Pr
Affiliation: Centre Hospitalier de Belfort-Montbelliard
Role: PRINCIPAL_INVESTIGATOR
Name: Marion CHAUVENET, Dr
Affiliation: Centre Hospitalier Lyon Sud-Pierre Benite
Role: PRINCIPAL_INVESTIGATOR
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