A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer

Inclusion Criteria: Patients with metastatic and/or unresectable carcinoma of the stomach, who have measurable disease Life expectancy > 3 months Karnofsky Performance Status > 60% Absence of an active infection Granulocyte count of > 1,500/mm^3 Hemoglobin (Hgb) >= 9 mg/dl Serum bilirubin =< 1.5 mg/dl, regardless of liver involvement secondary to tumor Platelets > 100,000/mm^3 Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 2.5 x the institutional upper limit of normal Calculated creatinine clearance of > 60 ml/min Patients must have signed written informed consent Female patients of child-bearing potential must have a negative blood or urine pregnancy test within two weeks prior to initial study treatment Patients who have had prior chemotherapy or radiation therapy must have recovered from any toxicities prior to study entry Patients must have radiographic imaging to document measurable disease within 28 days prior to initial study therapy Exclusion Criteria: Diagnosis of resectable carcinoma of the stomach Major surgery within four weeks of study entry Brain metastasis or known seizure disorder Fertile men and women not using an acceptable method of contraception Pregnant or lactating patients are excluded since STI571 may be harmful to the developing fetus and child Patients known to be HIV positive and receiving HAART are excluded because of possibly pharmacological interactions Active peptic ulceration or active gastrointestinal bleeding or any active bleeding disorders Use of therapeutic doses of coumadin (warfarin) as anticoagulation Medical, social, or psychological factors which would prevent the patient from completing the treatment protocol Patients with serious intercurrent illness which would preclude tolerance and completion of the protocol treatment