Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer
Recruitment status was: Recruiting
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Drug: vinorelbine tartrate
Procedure: quality-of-life assessment
Other: questionnaire administration
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Weekly Vinorelbine and Paclitaxel in Elderly Patients With Advanced Non-small Cell Lung Cancer|
- Progression-free survival [ Time Frame: Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years ] [ Designated as safety issue: No ]The Kaplan-Meier method will be used to estimate time to event distributions.
- Non-hematological toxicity [ Time Frame: Up to week 17 ] [ Designated as safety issue: Yes ]Toxicity will be assessed at the 0.05 two-sided level of significance. The Common Terminology Criteria for Adverse Events Version 3.0 will be used to grade the severity of adverse events.
- Response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]The measurement of effect will be based on the Response Evaluation Criteria In Solid Tumors criteria.
|Study Start Date:||December 2007|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (vinorelbine tartrate, paclitaxel)
Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.
Drug: vinorelbine tartrate
Other Names:Drug: paclitaxel
Other Names:Procedure: quality-of-life assessment
Other Name: quality of life assessmentOther: questionnaire administration
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602797
|United States, Nebraska|
|Saint Francis Medical Center|
|Grand Island, Nebraska, United States, 68803|
|Great Plains Regional Medical Center|
|North Platte, Nebraska, United States, 69103|
|Omaha Veterans Administration Medical Center|
|Omaha, Nebraska, United States, 68105|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|United States, South Dakota|
|Avera McKennan Hospital and University Health Center|
|Sioux Falls, South Dakota, United States, 57105|
|Principal Investigator:||Apar Ganti||University of Nebraska|