CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Pemetrexed +1 moredrug
Likely dose
Pemetrexed 500 mg/m² IV plus gemcitabine 1500 mg/m²AI-extracted
Key inclusion· 7
  • Histologically confirmed non-small cell lung cancer
  • Newly diagnosed or recurrent unresectable stage III or IV disease
  • Measurable disease present
  • No prior antineoplastic chemotherapy for lung cancer
Key exclusion· 5
  • Pregnant or lactating females
  • Serious cardiovascular disease within the previous six months
  • Serious active infection at time of treatment
  • Other serious underlying medical condition

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

Search/NCT00193414
NCT00193414Phase 2Completed

Phase II Study of First-Line Therapy With Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer

SCRI Development Innovations, LLC·interventional·Posted Sep 19, 2005·Updated Mar 3, 2022

In Brief

A Phase 2 clinical trial evaluating Pemetrexed and Gemcitabine for Lung Cancer. Completed, enrolled 72 participants across 1 site.

Detailed Summary

This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartMay 1, 2005
Primary CompletionDec 1, 2008
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 20.8 years ago

Interventions

Pemetrexeddrug

500mg/m2 IV over 10 min, Day 1, prior to gemcitabine

Gemcitabinedrug

1500mg/m2, 30min IV