Study of Metformin Plus Paclitaxel/Carboplatin/Bevacizumab in Patients With Adenocarcinoma.

Phase 2 Terminated 25 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins National Cancer Institute (NCI) · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

To determine the 1 year progression-free survival (PFS) of the combination of metformin and standard chemotherapy in patients with previously untreated advanced or metastatic pulmonary adenocarcinoma.

Timeline

Start: 2012-05
Primary completion: 2017-01
Completion: 2017-01

Outcome

Met primary endpoint

Stopped (Enrollment): “Low enrollment”

paper The 1-year PFS on Arm A (n = 18) was 47% (95% confidence interval [CI]: 25%-88%), which exceeded the historical control 1-year PFS of 15%. PMID 29487223 ↗

paper To the authors' knowledge, this is the first study to show a significant benefit in PFS with the use of metformin in this patient population PMID 29487223 ↗

Publications

Results Marrone KA, Zhou X, Forde PM, Purtell M, Brahmer JR, Hann CL, Kelly RJ, Coleman B, Gabrielson E, Rosner GL, Ettinger DS. A Randomized Phase II Study of Metformin plus Paclitaxel/Carboplatin/Bevacizumab in Patients with Chemotherapy-Naive Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer. Oncologist. 2018 Jul;23(7):859-865. doi: 10.1634/theoncologist.2017-0465. Epub 2018 Feb 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	1000 mg	Oral
Background	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Background	Carboplatin	Small molecule	6 unknown	Intravenous
Background	Paclitaxel	Small molecule	200 mg/m2	Intravenous