Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine for Non-Small Cell Lung Cancer

NCT00193362 ↗

Phase 3 Completed 200 enrolled SCRI Development Innovations, LLC Eli Lilly and Company · collab GlaxoSmithKline · collab

RandomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the effectiveness of the three-drug combination paclitaxel, carboplatin, and gemcitabine to the two-drug combination gemcitabine and vinorelbine in patients with advanced Non-Small Cell Lung Cancer

Timeline

Start: 2004-06
Primary completion: 2005-06
Completion: 2007-09

Outcome

Missed primary endpoint

paper There was no difference in OS or progression-free survival when comparing PCG and gemcitabine/vinorelbine PMID 17922972 ↗

Publications

Results Greco FA, Spigel DR, Kuzur ME, Shipley D, Gray JR, Thompson DS, Burris HA, Yardley DA, Pati A, Webb CD, Gandhi JG, Hainsworth JD. Paclitaxel/Carboplatin/gemcitabine versus gemcitabine/vinorelbine in advanced non-small-cell lung cancer: a phase II/III study of the Minnie Pearl Cancer Research Network. Clin Lung Cancer. 2007 Sep;8(8):483-7. doi: 10.3816/CLC.2007.n.032.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	5 unknown	—
Subject	Gemcitabine	Small molecule	1000 mg/m2	—
Subject	Paclitaxel	Small molecule	200 mg/m2	—
Subject	Vinorelbine	Small molecule	25 mg/m2	—