NCT01443065

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Malignant Neoplasm of Esophagus
• Malignant Neoplasm of Stomach

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-03-01
• Completion: 2018-09-01
• First posted: 2011-09-29
• Last updated: 2020-11-17

Locations

1 site across 1 country: France