A Phase II Study of PN401, 5-FU, and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach.

Pt must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction. Must have locally advanced (i.e., unresectable) or metastatic disease. No prior chemotherapy for advanced or metastatic gastric cancer. Chemotherapy given adjuvantly or as a radiation sensitizer allowed if more than 6 months have elapsed since treatment was completed. Prior radiation therapy allowed if complete recovery from all radiation induced toxicities. At least 4 weeks must have elapsed from the completion of radiation therapy to the time of registration. No prior biologic therapy. Adequate bone marrow reserve, renal and hepatic function. No plans for concurrent therapy (radiation or biologics). No major surgical resection of intraabdominal organs within 3 weeks prior to registration and pt must have complete recovery from surgery prior to registration. No known brain metastases. If neurological signs or symptoms, brain imaging studies are required and must be negative. Patients must be able to swallow oral medication. No known AIDS syndrome or HIV associated complex. Non-pregnant or non-nursing.