MILES-02: Study of Chemotherapy Treatment and Toxicity in Elderly Patients With Advanced Non Small Cell Lung Cancer

Summary

The main purpose of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion, and of two 2-drug combinations containing cisplatin (cisplatin + vinorelbine, and cisplatin + gemcitabine) in the treatment of elderly patients with advanced non small cell lung cancer

Timeline

Start

2002-06

Primary completion

2006-12

Completion

2007-04

Outcome

Missed primary endpoint

paper Gemcitabine at prolonged constant infusion produced a response rate lower than that required by study design PMID 18683299 ↗

Publications

• Results Gridelli C, Maione P, Illiano A, Piantedosi FV, Favaretto A, Bearz A, Robbiati SF, Filipazzi V, Lorusso V, Carrozza F, Iaffaioli RV, Manzione L, Gallo C, Morabito A, Perrone F. Cisplatin plus gemcitabine or vinorelbine for elderly patients with advanced non small-cell lung cancer: the MILES-2P studies. J Clin Oncol. 2007 Oct 10;25(29):4663-9. doi: 10.1200/JCO.2007.12.5708.
• Results Gridelli C, De Maio E, Barbera S, Sannicolo M, Piazza E, Piantedosi F, Brancaccio L, Morabito A, Maione P, Renda F, Signoriello G, Perrone F; MILES Investigators. The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients. Lung Cancer. 2008 Jul;61(1):67-72. doi: 10.1016/j.lungcan.2007.12.002.

Drugs

Indications