FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine

Phase 2 Completed 127 enrolled Federation Francophone de Cancerologie Digestive GERCOR - Multidisciplinary Oncology Cooperative Group · collab UNICANCER · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The main objective of this trial is to evaluate every 2 months alternating nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the progression of disease at 6 months.

Timeline

Start: 2015-11
Primary completion: 2017-12
Completion: 2021-03

Publications

Results Rinaldi Y, Pointet AL, Khemissa Akouz F, Le Malicot K, Wahiba B, Louafi S, Gratet A, Miglianico L, Laharie H, Bouhier Leporrier K, Thirot Bidault A, Texereau P, Coriat R, Terrebonne E, Gouttebel MC, Malka D, Bachet JB, Lepage C, Taieb J; PRODIGE 37 Investigators/Collaborators. Gemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3, as first-line treatment for patients with metastatic pancreatic adenocarcinoma: The Federation Francophone de Cancerologie Digestive-PRODIGE 37 randomised phase II study (FIRGEMAX). Eur J Cancer. 2020 Sep;136:25-34. doi: 10.1016/j.ejca.2020.05.018. Epub 2020 Jul 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Irinotecan	Small molecule	90 mg/m2	Intravenous
Subject	Leucovorin	Small molecule	200 mg/m2	Intravenous
Subject	Leucovorin	Small molecule	400 mg/m2	Intravenous
Subject	Nab-paclitaxel	Small molecule	125 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	2000 mg/m2	Intravenous

FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine

Summary

Timeline

Publications

Drugs

Indications