drugset / Trial / NCT00754364

Mono Versus Polichemotherapy in Non Small Cell Lung Cancer (NSCLC) Elderly Patients

NCT00754364 ↗

Phase 2 Terminated 108 enrolled Armando Santoro, MD
RandomizedParallel-groupOpen-labelTreatment

Summary

Between 10% and 25% of newly diagnosed stage IIIB/stage IV patients currently receive single agent chemotherapy regimens. A significant proportion of these patients will be elderly (70 years of age) and many oncologists would consider intravenous vinorelbine or gemcitabine to be the standard of care in this patient population. It has been demonstrated that single agent vinorelbine offers therapeutic advantages to selected NSCLC patients over best supportive care alone. Carboplatin plus Alimta have an acceptable toxicity profile and few clinical problems so it could be acceptable its use in elderly patients. A randomised study is being performed therefore to assess whether progression free survival, the primary efficacy endpoint for this study, achieved with Carboplatin plus Alimta is superior than achieved with gemcitabine, one of the current standards of care in elderly patients with advanced NSCLC.

Timeline

Start
2008-10
Primary completion
2014-05
Completion
2015-12

Outcome

Outcome not reported

Stopped (Enrollment): “low enrollment rate”

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown Intravenous
Comparator Gemcitabine Small molecule 1250 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous