Clinical trial NCT01004601: Low Dose Weekly Docetaxel Versus Pemetrexed in Previously Treated Advanced Non-Small-Cell Lung Cancer
Official title: Chang Gung Memorial Hospital, Chang Gung University, College of Medicine, Taipei, Taiwan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: pretreated failure advanced stage IIIb/IV NSCLC
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2009-10-30
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective response rate
timeFrame: at least 3 cycles
Secondary outcomes:
measure: PFS-progression free survival
timeFrame: the time from the first cycle of chemotherapy to documented progression, or death from any cause
measure: OS-overall survival
timeFrame: from the start date of the treatment to death or to the last follow-up visit
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Han-Pin Kuo
role: PRINCIPAL_INVESTIGATOR
References:
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