Phase II trial of metformin and paclitaxel for patients with gemcitabine-refractory advanced adenocarcinoma of the pancreas

Ecancermedicalscience
Maria Ignez BraghiroliRachel P Riechelmann

Abstract

In patients with adenocarcinoma of the pancreas, there are no standard second-line regimens. Many pre-clinical studies have shown that metformin alone or when combined with paclitaxel has antitumour effects on this tumour. We have tested here the combination of paclitaxel and metformin for patients with gemcitabine-refractory pancreatic cancer. An uncontrolled phase II trial was carried out based on a two-stage Simon's design, with metformin and paclitaxel for patients with locally advanced or metastatic pancreatic cancer whose disease had progressed during first line treatment with a gemcitabine-based regimen. The primary endpoint was the disease control rate at eight weeks as per response evaluation criteria in solid tumours (RECIST) 1.1. Patients received paclitaxel 80 mg/m(2) weekly for three weeks every 28 days and metformin 850 mg p.o. t.i.d. continuously until progression or intolerance state was reached. Twenty patients were enrolled from July 2011 to January 2014: N = 6 (31.6%) achieved the primary endpoint, with all presenting stable disease. Median overall survival (OS) was 128 days (range 17-697) and the median progression free survival (PFS) was 44 days (range 14-210). Eight patients (40%) presented treatment-relat...Continue Reading

Citations

Jun 6, 2016·Clinical Colorectal Cancer·Vanessa C MirandaRachel P Riechelmann
May 11, 2016·Journal of Cancer Research and Clinical Oncology·Archana Bhaw-Luximon, Dhanjay Jhurry
Jan 12, 2019·Frontiers in Oncology·Ali Vaziri-GoharJordan M Winter
Mar 9, 2019·International Journal of Cancer. Journal International Du Cancer·Min WeiZhi-Jiang Zhang
Jul 28, 2017·Expert Opinion on Drug Safety·Marco TuccoriCorrado Blandizzi
Dec 3, 2016·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Benjamin D HopkinsLewis C Cantley
Feb 26, 2019·Frontiers in Oncology·Ali Vaziri-GoharJordan M Winter
Nov 23, 2016·Cancer Discovery·Claudio VernieriValter Longo
Apr 28, 2020·Life Sciences·Bin ZhaoPeng Shang
Apr 4, 2021·Pharmaceuticals·Rita RebeloCristina P R Xavier
Jun 5, 2021·Nutrition and Cancer·Mustafa B A Djamgoz, Valerie Jentzsch
May 20, 2021·World Journal of Gastroenterology : WJG·Ademar Dantas Cunha JúniorJosé Barreto Campello Carvalheira

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xenograft

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NCT01971034
NCT01101438

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