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 - TUD-Glivec-012

Technical University Dresden0 sites44 target enrollmentDecember 7, 2006

Conditionsadvanced carcinoma of the gallbladder and bile duct

DrugsGlivec

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: advanced carcinoma of the gallbladder and bile duct
Sponsor: Technical University Dresden
Enrollment: 44
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 7, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Technical University Dresden

Eligibility 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 \< 1,25 x upper normal limit or \< 1,5 x upper normal limit if hyperbilirubinemia is related to underlying disease, ALAT \+ ASAT \< 1,5 x upper normal limit, in case of liver metastases \< 5 x upper normal limit, creatinine \< 1,25 x upper normal limit)
•7\.Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Female patients with child\-bearing potential must perform a highly effective barrier method of birth control throughout the study with a proven efficacy of \>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

Exclusion Criteria

•1\.Patient has received any other investigational agents within 28 days of first day of study drug dosing.
•2\.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.
•3\.Female patients who are pregnant or breast\-feeding.
•4\.Patient has a severe and/or uncontrolled medical disease.
•5\.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).
•6\.Radiotherapy or any major abdominal or thoracic surgery \< 4 weeks before study entry (excluding diagnostic biopsy or port implantation)
•7\.Patient has received neoadjuvant imatinib mesylate or fluoropyrimidines prior to study entry
•8\.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)
•9\.Known incompatibility of imatinib,5\-FU, or leucovorin
•10\.Known brain metastases