Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

Phase 3 Completed 108 enrolled Sanofi

RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: To demonstrate that the addition of oxaliplatin to 5-Fluorouracil (5-FU) and Leucovorin (LV) will improve the Progression-Free Survival (PFS). Progression is based on RECIST (Response Evaluation Criteria In Solid Tumors) criteria or death Secondary Objective: To evaluate other measures of tumor responses, safety, quality of life (QoL), and health utility assessment.

Timeline

Start: 2010-07
Primary completion: 2013-10
Completion: 2013-10

Outcome

Missed primary endpoint

paper No difference was observed in PFS (median, 3.1 months v 2.9 months; P = .99). PMID 27621395 ↗

Publications

Gill S, Ko YJ, Cripps C, Beaudoin A, Dhesy-Thind S, Zulfiqar M, Zalewski P, Do T, Cano P, Lam WYH, Dowden S, Grassin H, Stewart J, Moore M. PANCREOX: A Randomized Phase III Study of Fluorouracil/Leucovorin With or Without Oxaliplatin for Second-Line Advanced Pancreatic Cancer in Patients Who Have Received Gemcitabine-Based Chemotherapy. J Clin Oncol. 2016 Nov 10;34(32):3914-3920. doi: 10.1200/JCO.2016.68.5776. Epub 2016 Sep 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Subject	Oxaliplatin	Small molecule	130 mg/m2	Intravenous
Background	Leucovorin	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous