PiCCA Study (Panitumumab in Combination With Cisplatin/Gemcitabine)

Summary

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.

Timeline

Start

2011-06

Primary completion

2016-09-12

Completion

2016-09-12

Outcome

Missed primary endpoint

paper PFS rate at 6 months was 54% in patients treated with cisplatin/gemcitabine and panitumumab but was 73% in patients treated with cisplatin/gemcitabine without antibody, respectively. PMID 29413685 ↗

paper Panitumumab in combination with chemotherapy does not improve ORR, PFS and OS in patients with KRAS wild-type, advanced biliary cancer. PMID 29413685 ↗

Publications

• Vogel A, Kasper S, Bitzer M, Block A, Sinn M, Schulze-Bergkamen H, Moehler M, Pfarr N, Endris V, Goeppert B, Merx K, Schnoy E, Siveke JT, Michl P, Waldschmidt D, Kuhlmann J, Geissler M, Kahl C, Evenkamp R, Schmidt T, Kuhlmann A, Weichert W, Kubicka S. PICCA study: panitumumab in combination with cisplatin/gemcitabine chemotherapy in KRAS wild-type patients with biliary cancer-a randomised biomarker-driven clinical phase II AIO study. Eur J Cancer. 2018 Mar;92:11-19. doi: 10.1016/j.ejca.2017.12.028. Epub 2018 Feb 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Panitumumab	Monoclonal antibody	9 mg/kg	Intravenous
Background	Cisplatin	Other / unclassified	25 mg/m2	—
Background	Gemcitabine	Small molecule	1000 mg/m2	—

Indications