A Phase II Study of Afatinib (BIBW 2992) in Patients with Advanced HER2-Positive Esophagogastric Cancer Refractory to Trastuzumab

Full Title

A Phase II Study of Afatinib in Patients with Advanced HER2-positive Trastuzumab-Refractory Advanced Esophagogastric Cancer

Purpose

Cancers of at the junction of the esophagus and stomach (esophagogastric cancers) that produce high levels of a protein called HER2 may be treated with trastuzumab, a drug that targets this protein. However, in some patients, the cancer continues growing despite trastuzumab therapy.

The goal of this study is to evaluate the safety and effectiveness of a drug called afatanib (also called BIBW 2992), which also targets HER2, in patients with metastatic esophagogastric cancer that has continued to grow despite trastuzumab treatment. Afatinib is a pill that is taken orally (by mouth). It is approved for treating some lung cancers; its use in this study is considered investigational.

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 esophagogastric cancer that has continued to grow despite trastuzumab treatment.
  • At least 2 weeks must have passed since completion of prior therapy (trastuzumab or lapatinib) and entry into the study.
  • Patients must be age 18 or older.

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

Protocol

11-166

Phase

II

Investigator

Co-Investigators