NCT00442026

Randomized Trial of Docetaxel and Gemcitabine Versus Gemcitabine in Elderly Patients With NSCLC

A Multicenter Randomized Phase III Study of the Docetaxel and Gemcitabine Combination Versus Monotherapy With Gemcitabine as First-line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 70 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This trial will compare the efficacy of the docetaxel and gemcitabine combination versus monotherapy with gemcitabine as first-line treatment in elderly patients with advanced NSCLC

Detailed description

Docetaxel and gemcitabine are well known active agents in the treatment of NSCLC. The standard treatment of elderly patients with advanced NSCLC is monotherapy with a third generation agent. However, there are only few randomized trials evaluating a two drug combination specifically addressed to elderly patients. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation

Conditions

• Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel at the dose of 30mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
DRUG	Gemcitabine	Gemcitabine at the dose of 900mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
DRUG	Gemcitabine	Gemcitabine at the dose of 1200mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2007-03-01
• Last updated: 2012-06-27

Locations

9 sites across 1 country: Greece