drugset / Trial / NCT00345059
The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the overall survival of patients with advanced non small cell lung cancer treated with docetaxel as single therapy versus docetaxel in combination with either gemcitabine or vinorelbine or in combination with capecitabine.
Timeline
- Start
- 2005-05
- Primary completion
- 2008-05
- Completion
- 2008-05
Publications
- Results Gebbia V, Morena R, Frontini L, Aitini E, Daniele B, Gamucci T, Di Maio M, Morabito A, Gallo C, Gridelli C. The DISTAL-2 phase III randomized trial of single agent weekly docetaxel (wD) vs wD plus gemcitabine (G) or vinorelbine (V) vs wD plus capecitabine (X) as second-line treatment of advanced non-small-cell lung cancer (NSCLC) patients (pts). J Clin Oncol 26: 2008 (May 20 suppl; abstr 19057)
- Results Gebbia V, Gridelli C, Verusio C, Frontini L, Aitini E, Daniele B, Gamucci T, Mancuso G, Di Maio M, Gallo C, Perrone F, Morabito A. Weekly docetaxel vs. docetaxel-based combination chemotherapy as second-line treatment of advanced non-small-cell lung cancer patients. The DISTAL-2 randomized trial. Lung Cancer. 2009 Feb;63(2):251-8. doi: 10.1016/j.lungcan.2008.05.027. Epub 2008 Jul 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 625 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 30 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 33.3 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | — |
| Subject | Vinorelbine | Small molecule | 20 mg/m2 | — |