Spots Global Cancer Trial Database for Efficacy of Imatinib and 5-FU/Leucovorin in Patients With Advanced Carcinoma of the Gallbladder and Bile Duct

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Trial Identification

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

Official Title: 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

Study ID: NCT01153750

Conditions

Advanced or Metastatic Cholangiocellular Carcinoma and Bile Duct

Interventions

Glivec

Study Description

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

Detailed Description: 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.