Low Dose Weekly Docetaxel Versus Pemetrexed in Previously Treated Advanced Non-Small-Cell Lung Cancer
Docetaxel and pemetrexed have been validated for previously treated advanced non-small cell lung cancer (NSCLC); however, tolerability is a concern with the docetaxel (tri-weekly 75 mg/m2 schedule). The investigators conducted this study to compare the efficacy and toxicity of weekly low-dose docetaxel versus tri-weekly pemetrexed for previously treated advanced NSCLC.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Chang Gung Memorial Hospital, Chang Gung University, College of Medicine, Taipei, Taiwan|
- Objective response rate [ Time Frame: at least 3 cycles ] [ Designated as safety issue: Yes ]
- PFS-progression free survival [ Time Frame: the time from the first cycle of chemotherapy to documented progression, or death from any cause ] [ Designated as safety issue: Yes ]
- OS-overall survival [ Time Frame: from the start date of the treatment to death or to the last follow-up visit ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2005|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Active Comparator: low dose docetaxel
Low dose single docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks)
patients at one university-affiliated hospital received low dose single docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks)following failure of previous treatment stage IIIb/IV NSCLC.
Active Comparator: Pemetrexed
Pemetrexed (500 mg/m2 every 3 weeks)
patients at one university-affiliated hospital received pemetrexed (500 mg/m2 every 3 weeks) following failure of previous treatment stage IIIb/IV NSCLC.
We have been following a schedule of weekly low dose docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks; 60 mg/m2 accumulated dose for each cycle) at our hospital in an effort to achieve better tolerability. We therefore performed an exploratory study, by statistical analyses, to investigate the efficacy and toxicity of such a low dose docetaxel schedule compared to that of pemetrexed in patients with NSCLC who have failed previous chemotherapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004601
|Chang Gung Memorial Hospital|
|Taipei, Taiwan, 10507|
|Principal Investigator:||Han-Pin Kuo||Chang Gung Memorial Hospital|