Panitumumab Plus Gemcitabine and Oxaliplatin (GEMOX)Versus GEMOX Alone to Treat Advanced Biliary Tract Adenocarcinoma
Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
Summary
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.