A Phase II Study of OSI-774 (NSC #718781) in Unresectable or Metastatic Adenocarcinoma of the Stomach and Gastroesophageal Junction

Histologically or cytologically confirmed adenocarcinoma of the stomach or GE junction that is locally advanced or metastatic. Tissue submission mandatory. No prior chemotherapy for advanced or metastatic gastric or GE junction cancer. Prior radiation therapy allowed if completely recovered from all radiation-induced toxicities. At least 4 weeks must have elapsed from the completion of radiation therapy to the time of registration. No surgery for gastric or GE junction cancer within 4 weeks prior to registration. No prior biologic therapy. Adequate bone marrow reserve, renal and hepatic function. Zubrod performance status 0-1. No history of corneal diseases. No evidence of active or uncontrolled infection, recent myocardial infarction, unstable angina, or life-threatening arrhythmia. No severe psychiatric disorders. No known HIV-positive. No GI tract disease resulting in inability to take medication. No known brain metastases. No plans for concurrent therapy. No other prior malignancy except as specified in the protocol. No pregnant or nursing women.