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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

Phase 2
18 Years
Open (Enrolling)
Malignant Neoplasm of Esophagus, Malignant Neoplasm of Stomach

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Trial Information

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

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)

Inclusion Criteria:

- Histologically proven adenocarcinoma of the stomach, the esophagus or the cardia
(with or without signet ring cells; intestinal, diffuse or mixed form).

- Locally advanced (non resectable) or metastatic disease.

- Measurable disease (at least one measurable tumor) according to the RECIST V1.1
criteria (the tumor should not be located in a previous field of radiation).

- Absence of previous palliative chemotherapy. Previous neo-adjuvant or adjuvant
chemotherapies (alone or combinated with radiotherapy) are authorized, including
biotherapy (except anti-EGFR or anti-c-Met / HGF), if it has been stopped at least 12
months before inclusion.

- Previous radiotherapy authorized if stopped at least 14 days before randomization and
if at least one measurable target outside the radiation area is present.

- No major surgery ≤ 28 days, or minor surgery ≤ 14 days, prior to randomization

- Sites of disease evaluated within 28 days prior to randomization with
thoracic-abdominal-pelvic CT scan (or abdominal-pelvic MRI plus Chest X-ray).

- Age ≥ 18 years.

- Patient general status : ECOG 0-1.

- Life expectancy ≥ 3 months.

- Hemoglobin > or = 9 g/L - (transfusion authorized if necessary), PNN ≥ 1,5.109/l,
platelets ≥ 100.109/l.

- Hepatic transaminases ≤ 2.5 times upper limit of normal (ULN) (≤ 5 ULN in case of
hepatic metastases), alkaline phosphatase ≤ 2.5 ULN (≤ 5 ULN in case of hepatic
metastases), total bilirubinemia ≤ 1.5 ULN)

- Creatinine clearance (calculated or measured) ≥ 50 ml / min, serum creatinine > 1.5

- Prothrombin time (PT) ≥ 60 %, INR < 1,5 (except if anticoagulant therapy)

- Magnesemia and calcemia ≥ Lower Limit of Normal (LLN)

- Negative Pregnancy test for women of child-bearing age.

- Information given to the patient and signed informed consent.

- Public Health insurance coverage.

- Sample of tumour (primitive or metastatic) available.

Exclusion Criteria:

- Known brain or leptomeningeal metastases.

- Positive HER2 Status (IHC 3+ or IHC2+/FISH or CISH+) .

- contraindication, allergy or hypersensitivity to ANY OF the study treatments.

- Prior Treatment with EGFR inhibitor or HGF / c-Met inhibitor.

- Patient already included in another clinical trial testing an experimental drug.

- Peripheral edema > grade 2.

- Proteinuria > 1 g/24h

- Clinically significant cardiovascular disease (such as unstable angina pectoris,
severe congestive heart failure, uncontrolled severe cardiac arrhythmia) within 12
months prior to randomization.

- Thrombosis or ischemic vascular event during the last 12 months (deep venous
thrombosis, pulmonary embolism, STROKE or established cerebral infarction, myocardial

- Medical history or signs of interstitial pneumopathy or pulmonary fibrosis.

- Peripheral neuropathy > grade 1.

- Clinically significant hemorrhage of the upper gastrointestinal tract (requiring
blood transfusion or hemostatic interventional procedure.

- Actively evolutive inflammatory bowel disease or any other intestinal disease causing
chronic diarrhea (≥ grade 2).

- Any uncontrolled concomitant disease (e.g., uncontrolled diabetes) or medical history
(e.g., organ transplantation) which, according to the opinion of the investigator,
may interfere with the interpretation of the study results.

- Any comorbidity or situation which, according to the opinion of the investigator,
could increase the risk of toxicity (e.g., Dihydropyrimidine dehydrogenase

- Chronic or active HIV, HBV or HCV infections.

- Severe and\or not healed wound.

- Any active infection requiring systemic treatment, or any uncontrolled infection
within 14 days before randomization.

- Other concomitant malignancy or history of cancer (except carcinoma in situ of the
cervix, or non melanoma skin cancer, with curative intent treatment), except when
considered in complete remission for at least 5 years before randomization.

- Pregnant women or women who might become pregnant during the study (or who plan to
become pregnant within 6 months after the last administration of a study drug) or
lactating women.

- Men or women who have the age of procreation and who do not abide with the use of a
highly efficient contraceptive means (according to the current institutional
standards) or, alternatively, the use of abstinence during the study treatment and
until 6 months after last administration of the study drugs.

- Patient unwilling to comply with the medical follow-up required by the trial because
of geographic social or psychological reasons.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 4 months

Outcome Description:

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

Outcome Time Frame:

4 months

Safety Issue:


Principal Investigator

David MALKA, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

PRODIGE 17 / ACCORD 20/0904



Start Date:

January 2011

Completion Date:

January 2019

Related Keywords:

  • Malignant Neoplasm of Esophagus
  • Malignant Neoplasm of Stomach
  • Adenocarcinoma
  • Locally advanced (non operable) or metastatic
  • First line treatment
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Esophageal Neoplasms
  • Stomach Neoplasms