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

Chang Gung Memorial Hospital, Chang Gung University, College of Medicine, Taipei, Taiwan

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01004601

Enrollment

179

Registered

2009-10-30

Start date

2005-03-31

Completion date

2008-10-31

Last updated

2009-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

pretreated failure advanced stage IIIb/IV NSCLC

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.

Interventions

DRUGdocetaxel

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.

DRUGpemetrexed

patients at one university-affiliated hospital received pemetrexed (500 mg/m2 every 3 weeks) following failure of previous treatment stage IIIb/IV NSCLC.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Objective response rate	at least 3 cycles

Secondary

Measure	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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026