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

Not Applicable

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: docetaxel; Drug: pemetrexed

• Registration Number: NCT01004601
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-10
• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-28
• Last Update Submitted: 2009-10-28
• Study First Posted: 2009-10-30
• Last Update Posted: 2009-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose docetaxel	docetaxel	Low dose single docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks)
Pemetrexed	pemetrexed	Pemetrexed (500 mg/m2 every 3 weeks)

Primary Outcome Measures

Name	Time	Method
Objective response rate	at least 3 cycles

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taipei, Taiwan