Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To evaluate the toxicity of combination therapy with AMG 337 (c-Met inhibitor AMG 337) and mFOLFOX6 (oxaliplatin, leucovorin calcium, and fluorouracil) chemotherapy in patients with advanced or metastatic gastrointestinal (GI) cancers. (Phase I) II. To determine the dose of AMG 337 to be used in combination with mFOLFOX6 chemotherapy in the phase II portion of the trial. (Phase I) III. To determine the pharmacokinetics of AMG 337 in combination with mFOLFOX6. (Phase I) IV. To determine if the addition of AMG 337 to mFOLFOX6 chemotherapy improves median progression-free survival (PFS) in the first line treatment of patients with human epidermal growth factor receptor 2 (Her2Neu) negative and high c-met proto-oncogene (MET) expressing advanced esophagogastric and gastroesophageal junction (GEJ) adenocarcinoma. (Phase II) SECONDARY OBJECTIVES: I. To evaluate the addition of AMG 337 to mFOLFOX6 chemotherapy and also to evaluate the placebo/mFOLFOX6 chemotherapy combination in the first line treatment of patients with Her2Neu negative and high c-MET expressing advanced esophagogastric and GEJ adenocarcinoma, with regards to overall survival (OS). (Phase II) II. To evaluate the addition of AMG 337 to mFOLFOX6 chemotherapy and also to evaluate the placebo/mFOLFOX6 chemotherapy combination in the first line treatment of patients with Her2Neu negative and high c-MET expressing advanced esophagogastric and GEJ adenocarcinoma, with regards to response rate and disease control rate. (Phase II) III. To evaluate the addition of AMG 337 to mFOLFOX6 chemotherapy and also to evaluate the placebo/mFOLFOX6 chemotherapy combination in the first line treatment of patients with Her2Neu negative and high c-MET expressing advanced esophagogastric and GEJ adenocarcinoma, with regards to toxicity rates. (Phase II) IV. To evaluate the addition of AMG 337 to mFOLFOX6 chemotherapy and also to evaluate the placebo/mFOLFOX6 chemotherapy combination in the first line treatment of patients with Her2Neu negative and high c-MET expressing advanced esophagogastric and GEJ adenocarcinoma, with regards to time to development of new metastasis. (Phase II) V. To evaluate the addition of AMG 337 to mFOLFOX6 chemotherapy and also to evaluate the placebo/mFOLFOX6 chemotherapy combination in the first line treatment of patients with Her2Neu negative and high c-MET expressing advanced esophagogastric and GEJ adenocarcinoma, with regards to evaluation of MET amplification. (Phase II) VI. To evaluate the addition of AMG 337 to mFOLFOX6 chemotherapy and also to evaluate the placebo/mFOLFOX6 chemotherapy combination in the first line treatment of patients with Her2Neu negative and high c-MET expressing advanced esophagogastric and GEJ adenocarcinoma, with regards to evaluation of MET amplification and MET expression as determined by DAKO immunohistochemistry (IHC) for comparison to Ventana IHC. (Phase II) VII. To evaluate the addition of AMG 337 to mFOLFOX6 chemotherapy and also to evaluate the placebo/mFOLFOX6 chemotherapy combination in the first line treatment of patients with Her2Neu negative and high c-MET expressing advanced esophagogastric and GEJ adenocarcinoma, with regards to a retrospective re-evaluation of the cutpoint used by the computer algorithm for c-MET IHC to assess its ability to distinguish responding versus non-responding patients will be undertaken in this population, so that a potentially more optimal cutpoint to define high c-MET tumors in patients can be identified. (Phase II) OUTLINE: This is a phase I, dose-escalation study of c-Met inhibitor AMG 337 followed by a phase II study. PHASE I: Patients receive c-Met inhibitor AMG 337 orally (PO) once daily (QD) on days 1-28; and oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive c-Met inhibitor AMG 337 PO QD on days 1-28; and oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46-48 hours on days 1 and 15. ARM B: Patients receive placebo PO QD on days 1-28; and oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46-48 hours on days 1 and 15. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02344810
Study type Interventional
Source Eastern Cooperative Oncology Group
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date March 6, 2015

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Not yet recruiting NCT05044312 - Sleep Disturbances in Surgical Patients With GI Cancers: A Quantitative and Qualitative Analysis N/A
Active, not recruiting NCT05053191 - Advancing Nursing Practices in Hospital Oncology Care N/A
Completed NCT03611309 - Perioperative Palliative Care Surrounding Cancer Surgery for Patients & Their Family Members N/A
Recruiting NCT03602677 - Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage N/A
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Not yet recruiting NCT06398314 - Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors N/A
Withdrawn NCT04030624 - Remote Electronic Patient Monitoring in Gastrointestinal Cancer N/A
Completed NCT02222259 - A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients N/A
Completed NCT02140593 - The Laparotomy Study Phase 4
Active, not recruiting NCT00716209 - Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers N/A
Recruiting NCT01484444 - Biomarker Analysis of Gastrointestinal Cancer N/A
Completed NCT02130427 - A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy N/A
Active, not recruiting NCT00710632 - Screening to Predict Weight Loss in Patients With Cancer N/A
Completed NCT00094965 - Oxaliplatin With FOLFOX4 in Patients With Normal and Abnormal Renal Function Phase 2
Terminated NCT04077372 - Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers N/A
Recruiting NCT04899908 - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases Phase 2
Recruiting NCT05429866 - Immunological Variables Associated to ICI Toxicity in Cancer Patients Phase 2
Recruiting NCT05226221 - Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality
Recruiting NCT03286348 - Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer N/A