NCT00319800

Second-Line Irinotecan or Gefitinib in Docetaxel Pretreated NSCLC

A Phase II Study of Second-Line Therapy With Irinotecan or Gefitinib in Docetaxel Pretreated Patients With Non-Small Cell Lung Cancer: a New Treatment Strategy According to Clinical Predictors for Response

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: Gachon University Gil Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To determine whether in docetaxel pretreated advanced NSCLC patients with favorable clinical parameter(s) gefitinib can produce different outcomes from patients without favorable clinical parameter treated with irinotecan.

Detailed description

It has been suggested that some clinical parameters, including women, no smoking history and a histologic diagnosis of adenocarcinoma, are associated with favorable outcomes of gefitinib therapy. We will conduct a phase II study in docetaxel pretreated advanced NSCLC patients treated with gefitinib or irinotecan according to these clinical parameters in order to determine whether in patients with favorable clinical parameter(s) gefitinib will produce difference outcomes from patients without favorable clinical parameter treated with irinotecan.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Gefitinib
DRUG	Irinotecan

Timeline

• Start date: 2006-02-01
• Completion: 2007-03-01
• First posted: 2006-04-27
• Last updated: 2008-03-12

Locations

1 site across 1 country: South Korea