Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma
Status:
Completed
Trial end date:
2008-02-01
Target enrollment:
Participant gender:
Summary
In Denmark approximately 200 new cases of cholangiocarcinoma are diagnosed every year. No
standard treatment exists for patients with advanced cholangiocarcinoma, and improved
systemic treatments are needed.
Duplets of gemcitabine, oxaliplatin and capecitabine have been evaluated in various cancers
and several different regimens are well tolerated and active, especially in upper
gastrointestinal cancers, exocrine pancreatic cancer and non-small cell lung cancer.
The triplet combination of these agents has not been studied, but a triplet combination of
gemcitabine, oxaliplatin and 5-FU infusion has been evaluated in a phase I study.
Bi-weekly combination of gemcitabine and oxaliplatin has proven active and tolerable and
warrants further study. In addition, fixed dose rate infusion of gemcitabine has shown
interesting as the ability of mononuclear cells to accumulate gemcitabine triphosphate during
therapy seems to be saturable.
We propose a phase I-II study of a bi-weekly schedule of gemcitabine, oxaliplatin and
capecitabine. This regimen could be feasible in an out-patients setting.
The phase I part is a standard dose escalation study for patients with solid tumors. In the
phase II part the recommended dose is studied in patients with advanced cholangiocarcinoma.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Rigshospitalet, Denmark
Collaborator:
Henrik Jensen, Dept. of Oncology, Vejle Sygehus, Vejle, Denmark