Molecularly Tailored Therapy for Patients With Metastatic Cancer of the Esophagus and Stomach

A Pilot Study of Molecular Profile-Directed Chemotherapy for Metastatic HER2(-) Esophagogastric Adenocarcinoma

The purpose of this study is to determine whether molecular profile-directed therapy (otherwise known as personalized treatment) can improve the effectiveness of standard chemotherapy combinations for patients with esophagogastric adenocarcinoma. A series of tests will be performed on a sample of tumor; based on the results of these tests, a patient will be assigned to a chemotherapy treatment.

Inclusion Criteria:

• Advanced, measurable metastatic esophagogastric adenocarcinoma by RECIST criteria
• Patients who have had surgery or radiotherapy with or without neoadjuvant or adjuvant chemotherapy (the wash-out period will be at least 1 month)
• Patients who are not eligible for resection and are chemotherapy naïve
• Patients with HER2(-) status
• Patients who have tumor deposit(s) that are easily accessible by ultrasound or CT guidance
• Patients must have adequate organ function
• Patients must provide written informed consent

Exclusion Criteria:

• Active concurrent malignancy, other than superficial, non-squamous cell carcinoma of the skin or uterine cervix, within the past three years
• ECOG performance status worse than 2
• Prior oral or intravenous chemotherapy for metastatic disease
• Patients with comorbidities that prevent them from being able to receive the chemotherapy regimen
• cardiac ejection fraction 45% or greater