Efficacy of Imatinib and 5-FU/Leucovorin in Patients With Advanced Carcinoma of the Gallbladder and Bile Duct

Exclusion Criteria

• •Patient has received any other investigational agents within 28 days of first day of study drug dosing.
• •Patient is \< 5 years free of another primary malignancy, except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ.
• •Female patients who are pregnant or breast-feeding.
• •Patient has a severe and/or uncontrolled medical disease.
• •The concurrent use of warfarin or acetaminophen are not allowed with imatinib mesylate and need to be replaced by other medications (e.g. by low molecular heparins in case of warfarin).
• •Radiotherapy or any major abdominal or thoracic surgery \< 4 weeks before study entry (excluding diagnostic biopsy or port implantation)
• •Patient has received neoadjuvant imatinib mesylate or fluoropyrimidines prior to study entry
• •Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
• •Known incompatibility of imatinib,5-FU, or leucovorin
• •Known brain metastases
• •Concurrent systemic chemotherapy, immunotherapy, hormone therapy
• •History of severe psychiatric illness
• •Drug- or alcohol abuse
• •Patient has know chronic liver disease (i.e., chronic active hepatitis, and cirrhosis)
• •Patients with dihydropyrimidine dehydrogenase deficiency (i.e. Treatment with Zostex)
• •Patients that are associated with or dependent of the investigator or sponsor
• •Patients with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
• •Patients with a creatinine clearance of \< 50ml/min.
• •Patients with a severe decrease of bone marrow function
• •Patients with acute infections
• •Patients with severe decrease of liver function
• •Patients in reduced performance status (ECOG \> 2)
• •No active vaccinations should be performed while being on study treatment
• •Anemia caused by vitamin B12 deficiency