- Histologically or cytologically confirmed metastatic or unresectable solid tumor for
which standard curative or palliative measures do not exist or are no longer
- 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
- 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.
- 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,
- 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.