Phase II Study of Weekly Vinorelbine and Paclitaxel in Elderly Patients With Advanced Non-Small Cell Lung Cancer
I. To assess the safety and efficacy of a combination of vinorelbine and paclitaxel
administered weekly to elderly patients with advanced non-small cell lung cancer.
II. To assess the response rate of a combination of vinorelbine and paclitaxel administered
weekly to elderly patients with advanced non-small cell lung cancer.
III. To assess the quality of life of elderly patients with advanced non-small cell lung
cancer during administration of weekly paclitaxel and vinorelbine.
Patients receive vinorelbine tartrate intravenously (IV) over 6-10 minutes and paclitaxel IV
over 1 hour once weekly for 6 weeks. Treatment repeats every 8 weeks for up to 2 courses in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 5 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Defined as the time from 1st therapy until first documentation of clinical progression or relapse or death. The Kaplan-Meier method will be used to estimate time to event distributions.
Every 3 months for 2 years and then every 6 months for 5 years
University of Nebraska
United States: Institutional Review Board
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|
|Great Plains Regional Medical Center||North Platte, Nebraska 69101-6598|
|Saint Francis Medical Center||Grand Island, Nebraska 68802|
|Omaha Veterans Administration Medical Center||Omaha, Nebraska 68105|