A Randomized Study Evaluating the Efficacy and Safety of MetMab in Combination of 5FU and mFOLOFOX6 in Patients With Metastatic HER2-Negative Gastroesophageal Cancer

What is the purpose of this trial?

THE Met RECEPTOR Receptors are specific sites on the surface of cancer cells that tell the cell to do something, such as grow, die, divide, or other actions. The Met receptor has been shown to be important in cancer growth, survival, and spread in a number of cancer types, including gastric cancer. Cancer cells can be tested for the presence of the Met receptor by evaluating a sample of the patient’s tumor. Approximately 50%70% of the patients who have gastric cancer will have a positive test result for the Met receptor. To be eligible for this study, you will need to agree to have a sample of your tumor tested for the Met receptor. The results of the Met receptor test will not be provided to either you or your doctor so that the care provided to you or any other patient is not influenced by the Met test result. The Met test result will be made available upon request at the end of your participation in this study. ONARTUZUMAB (MetMAb) This is a study of an investigational medicine called onartuzumab (MetMAb), to be used in combination with chemotherapy. The word “investigational” means that onartuzumab is being tested for treatment of gastric cancer. Onartuzumab is an experimental (not yet approved by the U.S. Food and Drug Administration [FDA]) medicine produced by Roche using recombinant DNA technology. Onartuzumab is a monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection). Onartuzumab attaches to the Met receptor and prevents Met from activating tumor cells. Onartuzumab has been shown to prevent or slow the growth of several different types of human cancer cells grown in animals, and has also shown activity in several types of cancer in early human testing. One study has tested onartuzumab in patients with lung cancer. This study, which enrolled 137 patients, evaluated the effects of onartuzumab or placebo (an inactive substance) when combined with erlotinib, another treatment for lung cancer. This study showed that patients with a positive test for the Met receptor (patients with Met diagnostic-positive tumors) who received onartuzumab plus erlotinib had a longer time before their disease worsened and a longer time alive than those treated with placebo + erlotinib. Patients who had a negative test for the Met receptor (patients with Met diagnostic-negative tumors) who received onartuzumab plus erlotinib had a shorter time before their disease worsened and a shorter time alive than those treated with placebo + erlotinib. The reason for this result is not fully understood. Your voluntary participation in this research study may help to determine whether a humanized antibody (onartuzumab) is safe and effective when given to patients with gastric cancer.

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Participation Guidelines

Click here for detailed information about who can participate in this trial.

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Dates:

Last Updated:

Study HIC#:

1209010837

Clinicaltrials.gov ID: Yale1528698