A Phase III Second Line Trial in Advanced Pancreatic Cancer CONKO 003

Expanded access Approved for marketing CONKO-Studiengruppe Amgen · collab Sanofi · collab medac GmbH · collab

Summary

The purpose of this study is to compare best supportive care plus oxaliplatin/ folinic acid/ 5-FU versus best supportive alone in patients with gemcitabine refractory pancreatic cancer.

Timeline

Start: —
Primary completion: —
Completion: —

Outcome

Met primary endpoint

paper was significantly improved (hazard ratio [HR], 0.66; 95% CI, 0.48 to 0.91; log-rank P = .010). PMID 24982456 ↗

paper Second-line OFF significantly extended the duration of overall survival when compared with FF alone PMID 24982456 ↗

Publications

Oettle H, Riess H, Stieler JM, Heil G, Schwaner I, Seraphin J, Gorner M, Molle M, Greten TF, Lakner V, Bischoff S, Sinn M, Dorken B, Pelzer U. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. J Clin Oncol. 2014 Aug 10;32(23):2423-9. doi: 10.1200/JCO.2013.53.6995. Epub 2014 Jun 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Leucovorin	Small molecule	200 mg/m2	Intravenous
Subject	Leucovorin	Small molecule	500 mg/m2	Intravenous
Subject	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	2 g	Intravenous
Subject	fluorouracil	Small molecule	2600 mg/m2	Intravenous