Phase II, Open-label, Randomized Clinical Trial of Panitumumab Plus Gemcitabine and Oxaliplatin (GEMOX) Versus GEMOX Alone as First Line Treatment in Advanced Biliary Tract Adenocarcinoma (Vecti-BIL)

NCT01389414 Phase 2 COMPLETED

This is a multi-centre phase II, open-label, randomized (1:1), parallel-arm, study of panitumumab in combination with chemotherapy (P-GEMOX) versus chemotherapy alone (GEMOX). Eligible subjects will be enrolled and randomized to receive first-line combination therapy consisting of panitumumab and GEMOX (experimental arm) or GEMOX alone (control arm).The ame of the Stuy is to evaluate the clinical activity of the P-GEMOX (Panitumumab and GEMOX) combination compared to GEMOX alone in patients with previously untreated surgically unresectable or metastatic biliary tract carcinoma (KRAS wild-type)and To evaluate the safety profile of the P-GEMOX combination; to assess the objective response rate; to assess overall survival; to study the correlation between biomarkers with activity and efficacy.

Details

Lead sponsor	Prof. Massimo Aglietta
Phase	Phase 2
Status	COMPLETED
Enrolment	89
Start date	2010-05
Completion	2015-05

Conditions

• Biliary Carcinoma

Interventions

• Panitumumab plus GEMOX chemotherapy
• GEMOX chemotherapy

Primary outcomes

• Progression-free survival — Every 8±1 Weeks until PD
  Progression-free survival (PFS), defined as the time from randomization to evidence of progression (RECIST, vers.1.1), death, or last radiographic assessment in absence of a PFS event.

Countries

Italy