Phase I/II Study of Nab-paclitaxel and Gemcitabine Followed by AG-mFOLFOX in Patients With Metastatic Pancreatic Adenocarcinoma

Phase 1/2 Completed 168 enrolled Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and efficacy of nab-paclitaxel (Abraxane) and gemcitabine followed by modified FOLFOX (AG-mFOLFOX) in patients with previously untreated, metastatic pancreatic adenocarcinoma

Timeline

Start: 2015-07
Primary completion: 2021-04
Completion: 2021-04

Outcome

Met primary endpoint

paper 12-month overall survival of 55.3% (95% confidence interval [CI], 44.2 to 66.5) versus 35.4% (95% CI, 24.9 to 46) in the control group (P=0.02). PMID 38320486 ↗

Publications

Carrato A, Pazo-Cid R, Macarulla T, Gallego J, Jimenez-Fonseca P, Rivera F, Cano MT, Rodriguez-Garrote M, Pericay C, Ales I, Layos L, Grana B, Iranzo V, Gallego I, Garcia-Carbonero R, de Mena IR, Guillen-Ponce C, Aranda E. Nab-Paclitaxel plus Gemcitabine and FOLFOX in Metastatic Pancreatic Cancer. NEJM Evid. 2024 Feb;3(2):EVIDoa2300144. doi: 10.1056/EVIDoa2300144. Epub 2024 Jan 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Leucovorin	Small molecule	—	—
Subject	Nab-paclitaxel	Small molecule	125 mg/m2	Intravenous
Subject	Oxaliplatin	Small molecule	—	—
Subject	fluorouracil	Small molecule	—	—