NCT01206049

Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations

Randomized Phase II Trial of Combination Chemotherapy With Panitumumab or Bevacizumab for Patients With Inoperable Cholangiocarcinoma Without KRAS Mutations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Vejle Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the rate of progression free survival of patients with inoperable cholangiocarcinoma 6 months after enrollment in the study. The patients are treated with combination chemotherapy supplemented by biological agents panitumumab or bevacizumab.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	1,000 mg/m2 on day 1 of a 2 weeks cycle
DRUG	Oxaliplatin	60 mg/m2 on day 1 of a 2 weeks cycle
DRUG	Capecitabine	1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle
DRUG	Panitumumab	6 mg/kg on day 1 of a 2 weeks cycle
DRUG	Bevacizumab	10 mg/kg on day 1 of a 2 weeks cycle

Timeline

• Start date: 2010-09-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2010-09-21
• Last updated: 2017-03-13

Locations

1 site across 1 country: Denmark