Panitumumab in Combination With Cisplatin/Gemcitabine Chemotherapy in Patients With Cholangiocarcinomas - a Randomized Clinical Phase II Study (PiCCA)

NCT01320254 Phase 2 COMPLETED

The purpose of this study is to determine the efficacy of panitumumab plus cisplatin/gemcitabine (CisGem) combination chemotherapy in KRAS wild-type biliary tract cancer patients without systemic pre-treatment, compared to the historical data and to the randomised control group without the antibody, which verifies the historically based assumption.

Details

Lead sponsor	Hannover Medical School
Phase	Phase 2
Status	COMPLETED
Enrolment	93
Start date	2011-06
Completion	2016-09-12

Conditions

• Cholangiocarcinomas

Interventions

• Cisplatin, Gemcitabine, Panitumumab
• Cisplatin, Gemcitabine

Primary outcomes

• progression-free survival rate — 6 months
  The progression-free survival rate at six months (primary endpoint) is defined as the number of patients recorded to be free of progression (according to RECIST) at this time point, divided by the number of patients randomized to the respective arm.

Countries

Germany