A Randomized Study Evaluating the Efficacy and Safety of MetMab in Combination of 5FU and mFOLOFOX6 in Patients With Metastatic HER2-Negative Gastroesophageal Cancer
Trial Purpose and Description
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.
- 18 and older
• ECOG performance status of 0 or 1
• Life expectancy >; 3 months
• Histologically confirmed adenocarcinoma of the stomach or GEJ with inoperable, metastatic
disease, not amenable to curative therapy
• Adequate archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tissue for central IHC assay of Met receptor and HER2 status (if unknown)
Local assessment of HER2 status is acceptable.
• Radiographic evidence of disease; measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Patients with peritoneal disease would generally be regarded as having evaluable disease and allowed to enter the trial.
• For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use an adequate method of
contraception (a method with a failure rate of <; 1% per year, such as hormonal implants, combined oral contraceptives, or a vasectomized partner) during the treatment period and
for at least 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin
• For men: agreement to use a barrier method of contraception during the treatment period and for at least 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin
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