drugset / Trial / NCT00003447
Vinorelbine and/or Gemcitabine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
RandomizedTreatment
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of vinorelbine, gemcitabine, or both in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Timeline
- Start
- 1998-07
- Primary completion
- —
- Completion
- —
Publications
- Results Gridelli C, Perrone F, Gallo C, Cigolari S, Rossi A, Piantedosi F, Barbera S, Ferrau F, Piazza E, Rosetti F, Clerici M, Bertetto O, Robbiati SF, Frontini L, Sacco C, Castiglione F, Favaretto A, Novello S, Migliorino MR, Gasparini G, Galetta D, Iaffaioli RV, Gebbia V; MILES Investigators. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst. 2003 Mar 5;95(5):362-72. doi: 10.1093/jnci/95.5.362.
- Results Gridelli C, Perrone S, Cigolari L, et al.: The MILES (Multicenter Italian Lung Cancer in the Elderly Study) phase 3 trial: gemcitabine + vinorelbine vs vinorelbine and vs gemcitabine in elderly advanced NSCLC patients. [Abstract] Proceedings of the American Society of Clinical Oncology A-1230, 2001.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1200 mg/m2 | Intravenous |
| Subject | Vinorelbine | Small molecule | 25 mg/m2 | Intravenous |
| Subject | Vinorelbine | Small molecule | 30 mg/m2 | Intravenous |