A Phase III Study of Standard Chemotherapy with and without Rilotumumab as Initial Treatment in Patients with Metastatic or Inoperable Gastric/Esophageal Cancer

Protocol
13-091
Full Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG 102) with Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
Phase
III
Purpose

Epirubicin, cisplatin, and capecitabine (ECX) is a combination of chemotherapy drugs used to treat metastatic and inoperable cancers of the stomach and the junction between the stomach and esophagus. However, many of these cancers return despite treatment. The purpose of this study is to see if adding the investigational drug rilotumumab to ECX chemotherapy is more effective than ECX alone when given as initial therapy in patients with metastatic or inoperable stomach and gastroesophageal cancers.

Rilotumumab works by blocking signals in the MET molecular pathway that drives cancer growth. It will only be given to patients whose cancer cells contain MET. Patients tumors’ also must not contain a protein called HER2; other treatments are available that target HER2.

Patients will be randomly assigned to receive ECX plus rilotumumab or ECX plus a placebo. Both treatments are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have cancer of the stomach or gastroesophageal junction that has metastasized or is inoperable.
  • Patients’ tumors should be positive for the MET protein and negative for HER2.
  • Patients may not have received prior chemotherapy, biologic therapy, or immunologic therapy for locally advanced or metastatic disease.
  • Any prior preoperative chemotherapy or chemo-radiation therapy must have been completed at least 6 months before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. David Ilson at 646-888-4183.

Disease(s)
Upper Gastrointestinal: Esophageal Cancer
Upper Gastrointestinal: Gastric Cancer
Locations
Related Diseases