Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors

Inclusion criteria

• Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective.
• SWOG performance status 0-2.
• ANC greater than 1500, platelets greater than 100,000.
• Total bilirubin less than 2 x upper limit of normal, or less than 3 x upper limit of normal in patients with liver metastasis. Transaminase (AST and/or ALT) less than 2 x upper limit of normal or less than 3 x upper limit of normal in patients with liver metastasis.
• Serum creatinine less than 1.25 x institutional upper limit of normal.
• Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.

Exclusion criteria

• Patient has received any other investigational agent- within 28 days of first day of study drug dosing.
• Patient with another primary malignancy except if the other primary malignancy is neither currently clinically significant nor requiring active intervention.
• Patient has another severe and/or life-threatening medical disease.
• Patient has an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis).
• Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
• Patient has received chemotherapy within 4 weeks (6 weeks for nitrosourea, mitomycin-C or any antibody therapy) prior to study entry unless urgent enrollment needed and approved by Novartis.
• Patient had a major surgery within 2 weeks prior to study entry.
• Patients with symptomatic brain metastasis.
• Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (e.g. congestive heart failure, myocardial infarction within 6 months of study)
• Medical, social or psychological factors interfering with compliance.
• Patients under therapeutic coumadin therapy.
• Patients under routine systemic corticosteroid therapy.