Neoplasms

All Conditions

Digestive System Diseases

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Adenocarcinoma

Stomach Neoplasms

Esophageal Neoplasms

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

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Stomach Diseases

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Esophageal Diseases

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Esophageal Cancer

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Leucovorin

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Oxaliplatin

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Rilotumumab

Vitamin B Complex

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Protective Agents

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Antineoplastic Agents, Immunological

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Folinic Acid

Folate

Vitamin B9

Every 2 weeks :

* Oxaliplatin : 85 mg/m2 over 120 mn (2h) IV on D1
* Folinic acid : 400 mg/m² (racemic form) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1 followed by :
* 5-fluoro-uracil : 400 mg/m² in IV bolus on D1 followed by :
* 5-fluoro-uracil : 2400 mg/m² in IV infusion over 46 h

Every 2 weeks :

* Oxaliplatin : 85 mg/m2 over 120 mn IV on D1
* Folinic acid : 400 mg/m² (racemic form) (or 200 mg/m² with L-folinic acid) over 2 h IV on D1 (in Y to oxaliplatin) followed by :
* 5-fluoro-uracil : 400 mg/m², IV bolus on D1, followed by :
* 5-fluoro-uracil : 2400 mg/m², IV infusion IV over 46 h
* Panitumumab : 6 mg/kg de 60 à 90 mn ± 15 mn IV every 14 days, just before chemotherapy administration (oxaliplatin and folinic acid), on Day 1 of each cycle. If the 1st infusion of panitumumab is well tolerated, the next infusions can be administered over 30 ± 10 mn.

Every 2 weeks :

* Oxaliplatin : 85 mg/m2 over 120 mn IV on D1
* Folinic Acid : 400 mg/m² (racemic) (or 200 mg/m² with L-folinic acid) over 2 h IV on D1 (in Y/concomitant with oxaliplatin) followed by :
* 5-fluoro-uracil : 400 mg/m² IV bolus on D1 followed by :
* 5-fluoro-uracil : 2400 mg/m² in IV perfusion over 46 h
* AMG 102 : 10 mg/kg over 60 ± 15 mn IV every 14 days, just before chemotherapy administration (oxaliplatin and folinic acid), on Day 1 of each cycle. If the first infusion is well tolerated (without severe infusion-related reactions), the following infusions can be administered over 30 ± 10 mn.

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

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

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

5-fluoro-uracil

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

panitumumab

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

AMG102

David MALKA, Dr

Eric FRANCOIS, Dr

Bruno BUECHER, Dr

Christophe BORG, Pr

Emmanuelle SAMALIN, Dr

You Heng LAM, Dr

François GHIRINGHELLI, Dr

Driffa MOUSSATA, Dr

Marie-Pierre GALAIS, Dr

Frédérique CVITKOVIC, Dr

Marie-Claire KAMINSKY, Dr

Olivier BOUCHE, Pr

Julien TAIEB, Pr

Cédric LECAILLE, Dr

Yves BECOUARN, Dr

Barbara DAUVOIS, Dr

Julien FORESTIER, Dr

Jaafar BENNOUNA, Dr

Christelle DE LA FOUCHARDIERE, Dr

Jean Baptiste BACHET, Dr

Jean Luc RAOUL, Dr

Leila BENGRINE LEFEVRE, Dr

Laurent MIGLIANICO, Dr

Laetitia DAHAN, Dr

Thomas APARICIO, Pr

Hervé PERRIER, Dr

Jean Philippe METGES, Dr

Eric TERREBONNE, Dr

Pascal ARTRU, Dr

Gaël DEPLANQUE, Dr

Emmanuel MAILLARD, Dr

Antoine ADENIS, Pr

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.

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)

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

based on the proportion of success in each patient group (patient without progression at 4 months)

Progression-free survival is defined as the time from randomization to progression (RECIST v1.1 criteria) or death. Patients alive without progression will be censored at the last tumoral evaluation and 5 years maximum.

Overall survival is defined as the time from randomization to death any cause or last follow-up news (censored data).

Time to progression is defined as the time from randomization to progression (RECIST v1.1 criteria). Patients alive without progression will be censored at the last tumoral evaluation. Patients died without progression will be censored at the death date any cause.

The objective tumor response will be evaluated by the investigator with RECIST v1.1 criteria every 8 (± 1) weeks up to disease progression. Patients with symptoms suggestive of disease progression will have a tumoral evaluation when symptoms will occur.

The Objective response duration is defined as time from first Complete Response or Partial Response to progression. Patients died without progression will be censored at death date.

The tumor control rate is rate of objective responses (complete responses and partial responses) and stable disease responses.

Tolerability of the treatment will be based on toxicities of evaluated products by clinical and biological measurements (NCIC/CTC (CTCAE V4) criteria, except for peripheral neuropathy toxicity (Lévi scale)).

UNICANCER

Spots Global Cancer Trial Database for locally advanced (non operable) or metastatic