FOLFOXIRI With or Without Panitumumab in Metastatic Colorectal Cancer (VOLFI)

Summary

The aim of the trial is to optimize response rates and rates of secondary resections of metastases in patients with initially non-resectable metastatic colorectal cancer of RAS wildtype. The patients will be treated in two therapy groups: Experimental arm A: Chemotherapy with FOLFOXIRI + panitumumab Standard arm B: Chemotherapy with FOLFOXIRI

Timeline

Start

2011-04

Primary completion

2017-06

Completion

2022-01

Outcome

Met primary endpoint

paper The ORR of the mFOLFOXIRI plus panitumumab arm exceeded 75% PMID 31609637 ↗

paper The ORR of the mFOLFOXIRI plus panitumumab arm exceeded 75% and was higher when compared with that of FOLFOXIRI PMID 31609637 ↗

Publications

• Modest DP, Martens UM, Riera-Knorrenschild J, Greeve J, Florschutz A, Wessendorf S, Ettrich T, Kanzler S, Norenberg D, Ricke J, Seidensticker M, Held S, Buechner-Steudel P, Atzpodien J, Heinemann V, Seufferlein T, Tannapfel A, Reinacher-Schick AC, Geissler M. FOLFOXIRI Plus Panitumumab As First-Line Treatment of RAS Wild-Type Metastatic Colorectal Cancer: The Randomized, Open-Label, Phase II VOLFI Study (AIO KRK0109). J Clin Oncol. 2019 Dec 10;37(35):3401-3411. doi: 10.1200/JCO.19.01340. Epub 2019 Oct 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irinotecan	Small molecule	150 mg/m2	—
Subject	Irinotecan	Small molecule	165 mg/m2	—
Subject	Panitumumab	Monoclonal antibody	6 mg/kg	Intravenous
Subject	fluorouracil	Small molecule	3000 mg/m2	—
Subject	fluorouracil	Small molecule	3200 mg/m2	—
Background	Leucovorin	Small molecule	200 mg/m2	—
Background	Oxaliplatin	Small molecule	85 mg/m2	—

Indications