Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: 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 FNCLCC-FFCD-AGEO PRODIGE 17-ACCORD 20 Randomized Phase II Trial
Study ID: NCT01443065
Study Description
Brief 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.
Detailed Description: Patients are randomised to modified FOLFOX6 (oxaliplatin 85 mg/m2, FA 400 mg/m², FU 400 mg/m² bolus then 2400 mg/m² over 46 hr) alone or combined to either panitumumab (6 mg/kg) or AMG 102 (10 mg/kg), every two weeks until unacceptable toxicity or disease progression. Judgment criteria include 4-month progression-free survival (PFS) rate (primary endpoint), OS, objective response rate, and safety. Ancillary studies aim to identify candidate predictive and prognostic biomarkers among functional of molecular alterations of the EGFR/RAS/RAF and HGF/c-Met pathways, and to monitor circulating tumour cells and circulating immune cells (myeloid derived suppressor cells, NK cells) in sequential blood samples taken at baseline and through the study treatment. A total of 165 pts will be enrolled (Fleming's one-step design)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Institut Gustave Roussy, Villejuif, , France
Contact Details
Name: David MALKA, Dr
Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
Role: PRINCIPAL_INVESTIGATOR
Name: Eric FRANCOIS, Dr
Affiliation: Centre Antoine Lacassagne-NICE
Role: PRINCIPAL_INVESTIGATOR
Name: Bruno BUECHER, Dr
Affiliation: Institut Curie Paris
Role: PRINCIPAL_INVESTIGATOR
Name: Christophe BORG, Pr
Affiliation: Hôpital Andre Boulloche-MONTBELIARD
Role: PRINCIPAL_INVESTIGATOR
Name: Emmanuelle SAMALIN, Dr
Affiliation: Centre Val d'Aurelle Paul Lamarque-MONTPELLIER
Role: PRINCIPAL_INVESTIGATOR
Name: You Heng LAM, Dr
Affiliation: Centre Paul Papin-ANGERS
Role: PRINCIPAL_INVESTIGATOR
Name: François GHIRINGHELLI, Dr
Affiliation: Centre Georges Francois Leclerc-DIJON
Role: PRINCIPAL_INVESTIGATOR
Name: Driffa MOUSSATA, Dr
Affiliation: Centre Hospitalier Lyon Sud-PIERRE BENITE
Role: PRINCIPAL_INVESTIGATOR
Name: Marie-Pierre GALAIS, Dr
Affiliation: Centre Francois Baclesse-CAEN
Role: PRINCIPAL_INVESTIGATOR
Name: Frédérique CVITKOVIC, Dr
Affiliation: Centre René Huguenin-SAINT-CLOUD
Role: PRINCIPAL_INVESTIGATOR
Name: Marie-Claire KAMINSKY, Dr
Affiliation: Centre Alexis Vautrin-VANDOEUVRE LES NANCY
Role: PRINCIPAL_INVESTIGATOR
Name: Olivier BOUCHE, Pr
Affiliation: Hôpital Robert Debré - REIMS
Role: PRINCIPAL_INVESTIGATOR
Name: Julien TAIEB, Pr
Affiliation: Hôpital Européen Georges Pompidou-PARIS (HEGP)
Role: PRINCIPAL_INVESTIGATOR
Name: Cédric LECAILLE, Dr
Affiliation: Polyclinique Bordeaux Nord Aquitaine-BORDEAUX
Role: PRINCIPAL_INVESTIGATOR
Name: Yves BECOUARN, Dr
Affiliation: Institut Bergonié Bordeaux
Role: PRINCIPAL_INVESTIGATOR
Name: Barbara DAUVOIS, Dr
Affiliation: Centre Hospitalier La Source-ORLEANS
Role: PRINCIPAL_INVESTIGATOR
Name: Julien FORESTIER, Dr
Affiliation: Hôpital Edouard Herriot-LYON
Role: PRINCIPAL_INVESTIGATOR
Name: Jaafar BENNOUNA, Dr
Affiliation: Centre René Gauducheau
Role: PRINCIPAL_INVESTIGATOR
Name: Christelle DE LA FOUCHARDIERE, Dr
Affiliation: Centre Leon Berard
Role: PRINCIPAL_INVESTIGATOR
Name: Christophe BORG, Pr
Affiliation: Centre Hospitalier Jean Minjoz
Role: PRINCIPAL_INVESTIGATOR
Name: Jean Baptiste BACHET, Dr
Affiliation: Centre Hospitalier La Pitié Salpétrière
Role: PRINCIPAL_INVESTIGATOR
Name: Jean Luc RAOUL, Dr
Affiliation: Institut Paoli-Calmettes
Role: PRINCIPAL_INVESTIGATOR
Name: Leila BENGRINE LEFEVRE, Dr
Affiliation: Hôpital Saint Antoine
Role: PRINCIPAL_INVESTIGATOR
Name: Laurent MIGLIANICO, Dr
Affiliation: CHP Saint Grégoire
Role: PRINCIPAL_INVESTIGATOR
Name: Laetitia DAHAN, Dr
Affiliation: Centre Hospitalier La Timone
Role: PRINCIPAL_INVESTIGATOR
Name: Thomas APARICIO, Pr
Affiliation: Hôpital Avicenne
Role: PRINCIPAL_INVESTIGATOR
Name: Hervé PERRIER, Dr
Affiliation: Hôpital Saint Joseph
Role: PRINCIPAL_INVESTIGATOR
Name: Jean Philippe METGES, Dr
Affiliation: CHU Morvan
Role: PRINCIPAL_INVESTIGATOR
Name: Eric TERREBONNE, Dr
Affiliation: Hôpîtal haut Lévèque
Role: PRINCIPAL_INVESTIGATOR
Name: Pascal ARTRU, Dr
Affiliation: Hôpital Privé Jean Mermoz
Role: PRINCIPAL_INVESTIGATOR
Name: Gaël DEPLANQUE, Dr
Affiliation: Groupe Hospitalier Saint Joseph
Role: PRINCIPAL_INVESTIGATOR
Name: Emmanuel MAILLARD, Dr
Affiliation: CHR Annecy
Role: PRINCIPAL_INVESTIGATOR
Name: Antoine ADENIS, Pr
Affiliation: Centre Oscar Lambret
Role: PRINCIPAL_INVESTIGATOR
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