Second-Line Irinotecan or Gefitinib in Docetaxel Pretreated NSCLC

Phase 2

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT00319800
• Lead Sponsor: Gachon University Gil Medical Center

Brief 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.

Study Timeline

• Study Start: 2006-02
• Study First Posted: 2006-04-27
• Study First Submitted: 2006-04-28
• Study First Submitted QC: 2006-04-28
• Study Completion: 2007-03
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-10
• Last Update Posted: 2008-03-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• aged 75 years or less
• histologically or cytologically confirmed non-small cell lung cancer
• advanced, metastatic or recurrent
• ECOG performance status 0 to 2
• one prior palliative chemotherapy including docetaxel
• measurable or evaluable indicator lesion(s)
• normal marrow, hepatic and renal function
• provision of written informed consent

Exclusion Criteria

• active infection and/or severe comorbidities
• pregnant or breastfed women
• active CNS metastasis
• active bleeding in GI tract or elsewhere

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Objective response rate
Progression-free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival
Toxicity

Trial Locations

Locations (1)

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of