Randomized Phase II Trial of Two Different Schedules of Docetaxel Plus Cisplatin as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
The combination of docetaxel 75 mg/m2 and cisplatin 60-80 mg/m2 administered every 3 weeks
is one of the most commonly used chemotherapy regimen in Korea for the first-line treatment
of advanced NSCLC. Although the 3-weekly regimen is active and tolerated, it is associated
with a significant incidence of severe neutropenia, often complicated by fever. Therefore,
there has been increasing interest in the use of a weekly administration of docetaxel as a
way of reducing its hematologic toxicity. We designed this randomized phase II trial to
evaluate the safety profile and antitumor activity of two different schedules of docetaxel
plus cisplatin given as first-line therapy in patients with advanced NSCLC.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
Se Hoon Park, MD
Principal Investigator
Gachon University Gil Medical Center, Incheon, Korea
Korea: Food and Drug Administration
GMO-LU-42
NCT00319514
April 2004
October 2006
Name | Location |
---|