A Single Arm Phase 2 Study of Pemetrexed as 2nd-Line Treatment of Advanced Non-Small Cell Lung Cancer
Status:
Completed
Trial end date:
2005-10-01
Target enrollment:
Participant gender:
Summary
In previous phase 2 studies, pemetrexed has shown antitumor activity in advanced non-small
cell lung cancer as a single agent as well as in combination with cisplatin. Since the
introduction of vitamin supplementation, pemetrexed has shown good tolerance and high safety.
Vitamin supplementation has opened the opportunity to offer patients higher pemetrexed
dosing, as has been demonstrated by a recent Phase 1 study. The higher dose with
supplementation may increase pemetrexed's efficacy without unduly compromising safety. The
present Phase 2 study will use pemetrexed dosing that is tailored to individual patient
tolerance, and is an effort to determine the efficacy and safety of this approach in patients
with advanced NSCLC who had prior chemotherapy.