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C-Met Inhibitor AMG 337, Oxaliplatin, Leucovorin Calcium, and Fluorouracil in Treating Patients With Advanced Stomach or Esophageal Cancer

NCT02344810 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-05-25

No results posted yet for this study

Summary

This partially randomized phase I/II trial studies the side effects and best dose of c-Met inhibitor AMG 337 when given together with oxaliplatin, leucovorin calcium, and fluorouracil and to see how well they work in treating patients with stomach or esophageal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. C-Met inhibitor AMG 337 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as, oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving c-Met inhibitor AMG 337 with oxaliplatin, leucovorin calcium, and fluorouracil may kill more tumor cells.

Conditions

  • Adenocarcinoma of the Esophagus
  • Adenocarcinoma of the Gastroesophageal Junction
  • Diffuse Adenocarcinoma of the Stomach
  • Gastrointestinal Cancer
  • Intestinal Adenocarcinoma of the Stomach
  • Mixed Adenocarcinoma of the Stomach
  • Stage IIIA Esophageal Cancer
  • Stage IIIA Gastric Cancer
  • Stage IIIB Esophageal Cancer
  • Stage IIIB Gastric Cancer
  • Stage IIIC Esophageal Cancer
  • Stage IIIC Gastric Cancer
  • Stage IV Esophageal Cancer
  • Stage IV Gastric Cancer

Interventions

DRUG

c-Met inhibitor AMG 337

Given PO

OTHER

placebo

Given PO

DRUG

oxaliplatin

Given IV

DRUG

leucovorin calcium

Given IV

DRUG

fluorouracil

Given IV

OTHER

pharmacological study

Correlative studies

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • ECOG-ACRIN Cancer Research Group

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Lakshmi Rajdev · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-06
Primary Completion
2015-03-06

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02344810 on ClinicalTrials.gov