Randomized Trial of Docetaxel and Gemcitabine Versus Gemcitabine in Elderly Patients With NSCLC

NCT00442026 ↗

Phase 3 Terminated 106 enrolled Hellenic Oncology Research Group University Hospital of Crete · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial will compare the efficacy of the docetaxel and gemcitabine combination versus monotherapy with gemcitabine as first-line treatment in elderly patients with advanced NSCLC

Timeline

Start: 2006-12
Primary completion: 2010-05
Completion: 2010-05

Outcome

Missed primary endpoint

Stopped (Enrollment): “Due to poor accrual”

paper There was no difference in terms of median OS (14.6 vs 12.2months; p=0.121) PMID 27264267 ↗

Publications

Karampeazis A, Vamvakas L, Kotsakis A, Christophyllakis C, Kentepozidis N, Chandrinos V, Agelidou A, Polyzos A, Tsiafaki X, Hatzidaki D, Georgoulias V. Docetaxel plus gemcitabine versus gemcitabine in elderly patients with advanced non-small cell lung cancer and use of a geriatric assessment: Lessons from a prematurely closed Hellenic Oncology Research Group randomized phase III study. J Geriatr Oncol. 2017 Jan;8(1):23-30. doi: 10.1016/j.jgo.2016.05.002. Epub 2016 Jun 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	30 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	900 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1200 mg/m2	Intravenous