Neoplasms

All Conditions

Rare Diseases

Carcinoma

Cholangiocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Bile Duct Cancer

Gallbladder Cancer

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Leucovorin

Fluorouracil

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

All patients will receive Glivec® 600 mg once daily without dose escalation. Glivec® will be given on day -4, -3, -2, -1, 1, 2, 3 and 4. There will be no day "0". Patients will also receive 5-FU (2000mg/qm 24hc.i. d1 + d2) and leucovorin (200mg/qm 2h-infusion) qd15.

Glivec

Jan Stoehlmacher, PD Dr.

To test the efficacy of a combination chemotherapy of imatinib and 5-FU in advanced or metastatic cholangiocellular carcinoma.

Efficacy: Tumor assessments should be performed by a CT or MRI scan, throughout the study. All assessments should be performed within 14 days of the scheduled day according to the visit schedules, and whenever clinically indicated otherwise. Radiological studies must use the same techniques as used at baseline. Evaluation will be based on RECIST criteria.

Safety: Safety assessments will consist of evaluating adverse events and serious adverse events, laboratory parameters including hematology, chemistry, vital signs, physical examinations, and documentation of all concomitant medications and/or therapies.

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

Phase II Study to Evaluate the Efficacy of a Chemotherapy Combination With Imatinib (Glivec®) and 5-FU/Leucovorin in Patients With Advanced Carcinoma of the Gallbladder and Bile Duct

University Hospital Dresden

PD Dr. Jan Stoehlmacher

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of Imatinib and 5-FU/Leucovorin in Patients With Advanced Carcinoma of the Gallbladder and Bile Duct	NCT01153750	Advanced or Met...	Glivec	18 Years -	University Hospital Dresden
Efficacy of Imatinib and 5-FU/Leucovorin in Patients With Advanced Carcinoma of the Gallbladder and Bile Duct	NCT01153750	Advanced or Met...	Glivec	18 Years -	University Hospital Dresden

Spots Global Cancer Trial Database for advanced or metastatic cholangiocellular carcinoma and bile duct