A Comparison of Two Doses of Pemetrexed in Patients Who Have Lung Cancer

Summary

The purposes of this study are to determine: * the safety of pemetrexed and any side effects that might be associated with it * how much pemetrexed should be given to patients. It is possible that information collected during this study will be analyzed by the Sponsor in the future to evaluate pemetrexed for other possible uses or for other medical or scientific purposes other than those currently proposed. Although pemetrexed has been shown to be effective in some patients with non-small-cell lung cancer, pemetrexed might not have beneficial effects for all patients.

Timeline

Start

2003-12

Primary completion

2006-10

Completion

2008-04

Outcome

Missed primary endpoint

paper No statistical difference was observed between the treatment arms (P500 versus P900) for median survival PMID 18283036 ↗

paper P900 did not improve any efficacy measure over P500. PMID 18283036 ↗

Publications

• Results Cullen MH, Zatloukal P, Sorenson S, Novello S, Fischer JR, Joy AA, Zereu M, Peterson P, Visseren-Grul CM, Iscoe N. A randomized phase III trial comparing standard and high-dose pemetrexed as second-line treatment in patients with locally advanced or metastatic non-small-cell lung cancer. Ann Oncol. 2008 May;19(5):939-45. doi: 10.1093/annonc/mdm592. Epub 2008 Feb 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pemetrexed	Small molecule	500 mg/m2	Intravenous
Subject	Pemetrexed	Small molecule	900 mg/m2	Intravenous

Indications