Biliary Tract Carcinoma
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of gemcitabine and cisplatin in Korean patients with biliary tract (bile tracts of the gallbladder or liver) cancer.
Interventions
DRUGgemcitabine
DRUGcisplatin
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histologic or cytologic diagnosis of adenocarcinoma of the gallbladder, intra/extrahepatic bile ducts or papilla of Vater with locally advanced or metastatic disease (at study entry) that is not amenable to curative surgical resection or with recurrent disease after prior surgical resection or radiotherapy. * Disease status must be measurable disease defined as: Bi-dimensionally measurable lesions with clearly defined margins and two perpendicular diameters that are clearly measurable by following: * Computerized tomography (CT) or magnetic resonance imaging (MRI), with one diameter 2.0 cm or greater and the other diameter 1.0 cm or greater. * Palpable Lesion, with both diameters 2 cm or greater. Disease progressing in areas of prior radiation therapy may be included. * Patients must have received no prior chemotherapy for advanced disease. * Prior radiotherapy must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
Exclusion criteria
* Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. * Heart failure, angina pectoris or arrhythmia that are poorly controlled in spite of medication or acute myocardial infarction within 6 months preceding study enrollment * Severe neurological or mental disorder. * Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy. * Poorly controlled diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the quantitative and qualitative toxicities of gemcitabine combined with cisplatin in this patient population. | — |
| To evaluate the following time-to-event efficacy variables: Duration of response, Time to treatment failure, Time to documented disease progression, Overall survival | — |
Countries
South Korea
Outcome results
None listed