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Malignant Neoplasm of EsophagusPhase 2MEGANCT01443065

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

A Phase 2 study testing Oxaliplatin, Folinic Acid and 5-fluoro-uracil in people with Malignant Neoplasm of Esophagus and Malignant Neoplasm of Stomach, run by UNICANCER at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oxaliplatin, Folinic Acid and 5-fluoro-uracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 siteFrance
Study dates
Jan 2011to Sep 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 ULN
  • 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.

Who cannot join

  • 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.
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  • 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 infarction).
  • 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 deficiency).
  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

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

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.

Read the 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)

Being tested
Oxaliplatin, Folinic Acid, 5-fluoro-uracil, panitumumab, AMG102
Keywords
Adenocarcinoma, Locally advanced (non operable) or metastatic, First line treatment
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxaliplatinDrug

    Also called Eloxatine

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

  • Folinic AcidDrug

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

  • 5-fluoro-uracilDrug

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

  • panitumumabDrug

    Also called Vectibix

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

  • AMG102Drug

    Also called Rilotumumab

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

Study groups in NCT01443065
Study groupRoleWhat they receive
Arm A : simplified Folfox 4Active comparatorEvery 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
Receives: Drug: Oxaliplatin; Drug: Folinic Acid; Drug: 5-fluoro-uracil
Arm B : simplified FOLFOX 4 + panitumumabExperimentalEvery 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.
Receives: Drug: Oxaliplatin; Drug: Folinic Acid; Drug: 5-fluoro-uracil; Drug: panitumumab
Arm C : simplified FOLFOX 4 + AMG 102ExperimentalEvery 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.
Receives: Drug: Oxaliplatin; Drug: Folinic Acid; Drug: 5-fluoro-uracil; Drug: AMG102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival at 4 months

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

    Measured: 4 months

Secondary outcomes (7)

  1. Progression-free survival

    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.

    Measured: until progression or death

  2. Overall survival

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

    Measured: until death

  3. Time to progression

    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.

    Measured: 4 months

  4. Objective tumor response rate (OR) (= complete responses [CR] + partial responses [PR]) according to RECIST V1.1

    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.

    Measured: until progression

  5. Objective response duration

    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.

    Measured: until progression

  6. Disease control rate (Complete Response + Partial Response + stable disease [SD])

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

    Measured: 4 months

  7. Tolerance of the treatment

    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)).

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionMar 2014
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01443065
Sponsor's protocol ID
PRODIGE 17 / ACCORD 20/0904
Other IDs
2009-012797-12, 2009
Acronym
MEGA
Status last verified
Nov 2020
First submitted
11 Aug 2011
Last updated
17 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin, Folinic Acid and 5-fluoro-uracil in people with Malignant Neoplasm of Esophagus and Malignant Neoplasm of Stomach, run by UNICANCER at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival at 4 months (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01443065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.

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