A Phase II Study of PN-401, 5-FU and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach

Study start date: February 1, 2001

DISEASE CHARACTERISTICS: Histologically or cytologically proven unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction No known brain metastases Negative brain imaging required for neurologic signs and symptoms PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver tumor present) Renal: Creatinine no greater than ULN Other: Not pregnant or nursing Fertile patients must use effective contraception Must be able to swallow oral medication No AIDS syndrome or HIV-associated complex No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy No concurrent biologic therapy Chemotherapy: No prior chemotherapy for advanced or metastatic gastric cancer At least 6 months since prior chemotherapy as adjuvant or radiation sensitizer Endocrine therapy: Not specified Radiotherapy: At least 1 month since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 3 weeks since prior major surgical resection of intra-abdominal organs and recovered