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