drugset / Trial / NCT00779454
Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma
Non-randomizedFactorialOpen-labelTreatment
Summary
The purpose of this study is partly to continue the good experience the investigators have with chemotherapy and partly to optimize treatment of inoperable cholangiocarcinoma by adding a biological antibody to the treatment of patients with wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS).
Timeline
- Start
- 2008-09
- Primary completion
- 2016-03
- Completion
- 2016-03
Outcome
Met primary endpoint
paper The study met its primary endpoint with a fraction of PFS at six months of 52%. PMID 31838939 ↗
paper The primary end point, fraction of progression-free survival (PFS) at 6 months, was 31/42 [74%; 95% confidence interval (CI) 58% to 84%]. PMID 22367707 ↗
Publications
- Jensen LH, Andersen RF, Byriel L, Fernebro E, Jakobsen A, Lindebjerg J, Nottelmann L, Ploen J, Hansen TF. Phase II study of gemcitabine, oxaliplatin and capecitabine in patients with KRAS exon 2 mutated biliary tract cancers. Acta Oncol. 2020 Mar;59(3):298-301. doi: 10.1080/0284186X.2019.1701201. Epub 2019 Dec 14.
- Jensen LH, Lindebjerg J, Ploen J, Hansen TF, Jakobsen A. Phase II marker-driven trial of panitumumab and chemotherapy in KRAS wild-type biliary tract cancer. Ann Oncol. 2012 Sep;23(9):2341-2346. doi: 10.1093/annonc/mds008. Epub 2012 Feb 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 60 mg/m2 | — |
| Subject | Panitumumab | Monoclonal antibody | 6 mg/kg | Intravenous |