drugset / Trial / NCT00881296

Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer

NCT00881296 ↗

Phase 2 Completed 60 enrolled Hamamatsu University
RandomizedParallel-groupOpen-labelTreatment

Summary

A comparison of biweekly combination chemotherapy (gemcitabine plus carboplatin) with weekly gemcitabine in elder patients (\> 75) with previously untreated advanced non-small cell lung cancer. Primary objective is to determine the objective response rate (CR+PR by RECIST criteria) for biweekly gemcitabine and carboplatin combination chemotherapy versus weekly single gemcitabine as first-line therapy in elder advanced non-small lung cancer patients (\> 76 years) who have received no prior treatment for non-small lung cancer. As secondary objectives, adverse event profile, tolerability of biweekly gemcitabine and carboplatin combination chemotherapy, progression-free survival and overall survival will be evaluated in both patients with biweekly gemcitabine and carboplatin combination chemotherapy and weekly single gemcitabine. The study hypothesis is that biweekly combination chemotherapy of gemcitabine plus carboplatin may improve the efficacy.

Timeline

Start
2008-03
Primary completion
2011-03
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — Other
Comparator Gemcitabine Small molecule 1000 mg/m2 Other