Low Dose Weekly Docetaxel Versus Pemetrexed in Previously Treated Advanced Non-Small-Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Chang Gung Memorial Hospital, Chang Gung University, College of Medicine, Taipei, Taiwan

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: docetaxel
* Drug: pemetrexed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stage IIIb or IV NSCLC previous treatment with chemotherapy or tyrosin kinase inhibitor performance status less than 2 Exclusion Criteria: age less 18 years pregnancy performance status 3-4

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: low dose docetaxel<br>Low dose single docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks) | Drug: docetaxel<br>* 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.<br>|
| Active Comparator: Pemetrexed<br>Pemetrexed (500 mg/m2 every 3 weeks) | Drug: pemetrexed<br>* patients at one university-affiliated hospital received pemetrexed (500 mg/m2 every 3 weeks) following failure of previous treatment stage IIIb/IV NSCLC.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | at least 3 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS-progression free survival |  | the time from the first cycle of chemotherapy to documented progression, or death from any cause | 
| OS-overall survival |  | from the start date of the treatment to death or to the last follow-up visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pretreated failure advanced stage IIIb/IV NSCLC