advanced carcinoma of the gallbladder and bile duct
Conditions
Interventions
Trade Name: Glivec
Product Code: STI571
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Imatinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
Technical University Dresden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically/Cytologically confirmed diagnosis of advanced / metastatic carcinoma of the gallbladder or bill duct, which is unresectable or metastatic and therefore incurable with any conventional multimodality approach. 2. Performance status 0, 1 or 2 (ECOG) 3. Written, voluntary informed consent 4. Age > 18 years 5. Adequate bone marrow function (Granulocytes > 1,5 x 109/l, Hb > 10 g/dl, Platelets > 100 x 109/l) 6. Adequate hepatic and renal function ( bilirubin 99%. The contraception treatment should be performed for an additional six month following discontinuation from study treatment. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following discontinuation of study drug. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient has received any other investigational agents within 28 days of first day of study drug dosing. 2. Patient is 2) 23. No active vaccinations should be peformed while being on study treatment 24. Anemia caused by vitamin B12 deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the efficacy of a combination chemotherapy of imatinib and 5-FU in advanced or metastatic cholangiocellular carcinoma. Primary endpoint: Disease Control Rate (DCR) ;Secondary Objective: Secondary endpoints: Progression-free survival (PFS) Response rate (RR) Overall survival Toxicity Evaluation of molecular predictive markers for response and toxicity;Primary end point(s): To determine the disease control rate (DCR) as defined as DCR = CR+PR+SD following Imatinib mesylate in combination with 5-FU/leucovorin as assessed by radiographic means. All tumor measurements will be validated by an external review (radiologist). | — |
Countries
Germany
Outcome results
None listed