A Phase II Study of FOLFOX plus Regorafenib in Patients with Inoperable or Metastatic Esophageal and/or Stomach Cancer

Protocol
13-080
Full Title
Phase II Study of FOLFOX Plus Regorafenib in Patients with Unresectable or Metastatic Esophagogastric Cancer
Phase
II
Purpose

FOLFOX chemotherapy (which consists of the anticancer drugs oxaliplatin, 5-fluorouracil, and leucovorin) is a standard treatment for patients with esophageal and/or stomach cancer (esophagogastric cancer). Regorafenib is an anticancer drug that inhibits the growth of the blood vessels that tumors need to grow and spread. It is approved for treating colon cancer and a rare form of digestive cancer called gastrointestinal stromal tumor (GIST), but its use to treat esophagogastric cancer is considered investigational.

Doctors believe that giving FOLFOX with regorafenib may be more effective than giving FOLFOX alone. In this study, researchers are assessing the safety and effectiveness of FOLFOX plus regorafenib in patients with inoperable or metastatic esophagogastric cancer. FOLFOX is given intravenously (by vein), while regorafenib is taken orally (by mouth).

Eligibility

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

  • Patients must have inoperable or metastatic cancer of the esophagus, stomach, or the junction between the esophagus and stomach.
  • At least 6 months must have passed since completion of prior chemotherapy and 2 weeks since radiation therapy and entry into the study. Patients may not have previously received treatment for advanced disease.
  • Patients may not have had prior FOLFOX or regorafenib therapy.
  • 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 about this study and to inquire about eligibility, please contact Dr. Yelena Janjigian at 646-888-4186.

Disease(s)
Upper Gastrointestinal: Esophageal Cancer
Upper Gastrointestinal: Gastric Cancer
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