CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Pemetrexed - Before Protocol Amendment +1 moredrug
Likely dose
Pemetrexed - Before Protocol Amendment 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/NCT00370292
NCT00370292Phase 2Completed

Pemetrexed Monochemotherapy in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer. A Pilot Study to Define the Best Dosing Schedule for a Planned Phase II Randomized Trial

Eli Lilly and Company·interventional·Posted Aug 31, 2006·Updated Oct 20, 2009

In Brief

A Phase 2 clinical trial evaluating Pemetrexed - Before Protocol Amendment and Pemetrexed - After Protocol Amendment for Non Small Cell Lung Cancer. Completed, enrolled 19 participants across 1 site.

Detailed Summary

Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to monitor the blood values of these biomolecules at different time intervals, to optimize the synergism between pemetrexed and gemcitabine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2006
Enrollment StartSep 1, 2006
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.8 years ago

Interventions

Pemetrexed - Before Protocol Amendmentdrug

500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue

Pemetrexed - After Protocol Amendmentdrug

500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.