A phase I/II study of pemetrexed with sirolimus in advanced, previously treated non-small cell lung cancer.

ABSTRACT:

Background

Single-agent pemetrexed is a treatment for recurrent non-squamous non-small cell lung cancer (NSCLC) that provides limited benefit. Preclinical studies showed promising synergistic effects when the mammalian target of rapamycin (mTOR) inhibitor sirolimus was added to pemetrexed.

Methods

This was a single-institution phase I/II study of pemetrexed in combination with sirolimus. The primary endpoint for the phase I was to determine the maximum tolerated dose (MTD) and safety of the combination. The primary endpoint for the phase II portion was to determine the overall response rate at the MTD. Key eligibility criteria included recurrent, metastatic NSCLC, ECOG performance status of 0-2, and adequate organ function. Sirolimus was administered orally daily after an in

SUBMITTER: Komiya T 

PROVIDER: S-EPMC6626857 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature