Panitumumab Plus Gemcitabine and Oxaliplatin (GEMOX)Versus GEMOX Alone to Treat Advanced Biliary Tract Adenocarcinoma

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.

Timeline

Start

2010-05

Primary completion

2013-09

Completion

2015-05

Outcome

Missed primary endpoint

paper median PFS was 5.3 months (95% confidence interval, 3.3-7.2 months) in arm A and 4.4 months (95% confidence interval, 2.6-6.2 months) in arm B (P = .27). PMID 26540314 ↗

Publications

• Leone F, Marino D, Cereda S, Filippi R, Belli C, Spadi R, Nasti G, Montano M, Amatu A, Aprile G, Cagnazzo C, Fasola G, Siena S, Ciuffreda L, Reni M, Aglietta M. Panitumumab in combination with gemcitabine and oxaliplatin does not prolong survival in wild-type KRAS advanced biliary tract cancer: A randomized phase 2 trial (Vecti-BIL study). Cancer. 2016 Feb 15;122(4):574-81. doi: 10.1002/cncr.29778. Epub 2015 Nov 5.

Drugs

Indications