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

Chang Gung Medical Foundation

Status: Completed

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: docetaxel; Drug: pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT01004601

98-2587B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 179 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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179 participants in 2 patient groups

low dose docetaxel

Active Comparator group

Description:

Low dose single docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks)

Treatment:

Drug: docetaxel

Pemetrexed

Active Comparator group

Description:

Pemetrexed (500 mg/m2 every 3 weeks)

Treatment:

Drug: pemetrexed