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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Krankenhaus Nordwest, Frankfurt/ Main, Hessen, Germany
University Hospital, Dresden, Saxony, Germany
University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Schleswig-Holstein, Germany
Onkologische Schwerpunktpraxis Eppendorf, Hamburg, , Germany
Staedtisches Klinikum Magdeburg, Magdeburg, , Germany
Johannes-Gutenberg-Universität Mainz, Medical Department I, Mainz, , Germany
Ruppiner Kliniken GmbH, Neuruppin, , Germany
Praxisgemeinschaft Dr. Hancken und Partner, Stade, , Germany
Name: Jan Stoehlmacher, PD Dr.
Affiliation: University Hospital Dresden
Role: PRINCIPAL_INVESTIGATOR