A Phase II Study of Ramucirumab plus Chemotherapy in Patients with Metastatic Gastric and Gastroesophageal Junction Cancers

Full Title

Phase II Study of Ramucirumab with Trastuzumab and Capecitabine/Cisplatin in Patients with Metastatic HER2-Positive Gastroesophageal Junction and Gastric Cancer

Purpose

Cancers of the stomach and the junction between the esophagus and stomach that are positive for a protein called HER2 are treated with trastuzumab (a drug that targets HER2) and chemotherapy. However, the cancer often comes back or eventually continues to grow despite this therapy. Ramucirumab is a drug used to treat stomach and gastroesophageal junction cancers that have come back despite initial therapy.

In this study, researchers are assessing the safety and effectiveness of adding ramucirumab to trastuzumab and chemotherapy in patients with HER2-positive metastatic stomach and gastroesophageal junction cancer. Ramucirumab inhibits the growth of the blood vessels that tumors need to grow and spread by blocking the activity of a protein called VEGFR2.

All patients in this study will receive ramucirumab, trastuzumab, capecitabine, and cisplatin. All of the study medications 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 HER2-positive metastatic stomach or gastroesophageal junction cancer.
  • Patients may not have received prior therapy for metastatic disease. Previous chemotherapy or chemoradiation for earlier stage cancer is allowed if at least 6 months have passed since the completion of treatment and entry into 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 for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Yelena Janjigian at 646-888-4186.

Protocol

15-301

Phase

II

Investigator

Co-Investigators