MEGA (Met or EGFR Inhibition in Gastroesophageal Adenocarcinoma): FOLFOX Alone or in Combination With AMG 102 or Panitumumab as First-line Treatment in Patients With Advanced Gastroesophageal Adenocarcinoma

Summary

This multicentre, open-label, randomized phase II trial is ongoing in 30 centres in France. Main eligibility criteria include: histologically proven adenocarcinoma of the stomach, esophagus or gastroesophageal junction; locally advanced or metastatic disease; measurable disease (RECIST 1.1); no known HER2 overexpression; no prior palliative chemotherapy.

Conditions

• Malignant Neoplasm of Esophagus
• Malignant Neoplasm of Stomach

Interventions

DRUG

Oxaliplatin

85mg/m² over 120 mn every 2 weeks up to progression or toxicity

DRUG

Folinic Acid

400mg/m² over 120 mn every 2 weeks up to progression or toxicity

DRUG

5-fluoro-uracil

400mg/m² in bolus, then 2400mg/m² over 46 h every 2 weeks up to progression or toxicity

DRUG

panitumumab

6mg/kg over 60-90 mn every 2 weeks up to progression or toxicity

DRUG

AMG102

10mg/kg over 60 mn every 2 weeks up to progression or toxicity

Sponsors & Collaborators

• UNICANCER

  lead OTHER

Principal Investigators

• David MALKA, Dr · Gustave Roussy, Cancer Campus, Grand Paris

• Eric FRANCOIS, Dr · Centre Antoine Lacassagne, Nice

• Bruno BUECHER, Dr · Institut Curie Paris

• Christophe BORG, Pr · Hôpital Andre Boulloche-MONTBELIARD

• Emmanuelle SAMALIN, Dr · Centre Val d'Aurelle Paul Lamarque-MONTPELLIER

• You Heng LAM, Dr · Centre Paul Papin-ANGERS

• François GHIRINGHELLI, Dr · Centre Georges Francois Leclerc-DIJON

• Driffa MOUSSATA, Dr · Centre Hospitalier Lyon Sud-PIERRE BENITE

• Marie-Pierre GALAIS, Dr · Centre Francois Baclesse-CAEN

• Frédérique CVITKOVIC, Dr · Centre René Huguenin-SAINT-CLOUD

• Marie-Claire KAMINSKY, Dr · Centre Alexis Vautrin-VANDOEUVRE LES NANCY

• Olivier BOUCHE, Pr · Hôpital Robert Debré - REIMS

• Julien TAIEB, Pr · Hôpital Européen Georges Pompidou-PARIS (HEGP)

• Cédric LECAILLE, Dr · Polyclinique Bordeaux Nord Aquitaine-BORDEAUX

• Yves BECOUARN, Dr · Institut Bergonié Bordeaux

• Barbara DAUVOIS, Dr · Centre Hospitalier La Source-ORLEANS

• Julien FORESTIER, Dr · Hôpital Edouard Herriot-LYON

• Jaafar BENNOUNA, Dr · Centre René Gauducheau

• Christelle DE LA FOUCHARDIERE, Dr · Centre Leon Berard

• Christophe BORG, Pr · Centre Hospitalier Jean Minjoz

• Jean Baptiste BACHET, Dr · Centre Hospitalier La Pitié Salpétrière

• Jean Luc RAOUL, Dr · Institut Paoli-Calmettes

• Leila BENGRINE LEFEVRE, Dr · Hôpital Saint Antoine

• Laurent MIGLIANICO, Dr · CHP Saint Grégoire

• Laetitia DAHAN, Dr · Centre Hospitalier La Timone

• Thomas APARICIO, Pr · Hôpital Avicenne

• Hervé PERRIER, Dr · Hôpital Saint Joseph

• Jean Philippe METGES, Dr · CHU Morvan

• Eric TERREBONNE, Dr · Hôpîtal haut Lévèque

• Pascal ARTRU, Dr · Hôpital Privé Jean Mermoz

• Gaël DEPLANQUE, Dr · Groupe Hospitalier Saint Joseph

• Emmanuel MAILLARD, Dr · CHR Annecy

• Antoine ADENIS, Pr · Centre Oscar Lambret

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2014-03-31

Completion

2018-09-30

Countries

• France

Study Locations