CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
pemetrexed +1 moredrug
Likely dose
pemetrexed 500 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00887549
NCT00887549Phase 2Completed

An Exploratory, Prospective Phase II Study to Investigate Progression-Free Survival, Response and Overall Survival Seen With Pemetrexed/Cisplatin and the Role of Thymidylate Synthase Expression

Eli Lilly and Company·interventional·Posted Apr 24, 2009·Updated Jun 19, 2012

In Brief

A Phase 2 clinical trial evaluating pemetrexed and cisplatin for Non-Small Cell Lung Cancer. Completed, enrolled 70 participants across 14 sites in 2 countries.

Detailed Summary

Thymidylate synthase (TS) is a substance the body produces naturally. The purpose of this research is to determine if there is a link between TS production and how well patients respond to treatment of non-squamous non-small cell lung cancer (NSCLC). The aim for the future is that doctors could have a better understanding in advance about which patients might respond well to pemetrexed based on how much TS they produce.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIreland, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 24, 2009
Enrollment StartApr 1, 2009
Primary CompletionJul 1, 2010
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.2 years ago

Interventions

pemetrexeddrug

Induction Therapy: 500 milligrams per square meter (mg/m\^2), intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: 500 milligrams per square meter (mg/m\^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs

cisplatindrug

Induction Therapy: 75 mg/m\^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles