NCT01308840

Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer

Phase II Study of Gemcitabine, Oxaliplatin in Combination With Panitumumab in Kras/B-raf Wild-Type Unresectable or Metastatic Biliary Track and Gallbladder Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine disease response of GEMOX-Panitumumab (GEMOX-P) in KRAS/ BRAF wild-type, Stage IV, biliary tract and gallbladder cancer patients who have previously not received chemotherapy. This study will also examine the potential toxicities, progression-free and overall survival in this population.

Conditions

• Biliary Tract Cancer
• Gallbladder Cancer

Interventions

Type	Name	Description
DRUG	Panitumumab	Day 1 and 15 = 6 mg/kg IV
DRUG	oxaliplatin	Days 1 and 15 = 85mg/m2 IV
DRUG	gemcitabine	Days 1 and 15 = 1000 mg/m2 IV

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-03-04
• Last updated: 2016-08-17
• Results posted: 2016-08-17

Locations

2 sites across 1 country: United States