Second-Line Irinotecan or Gefitinib in Docetaxel Pretreated NSCLC

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00319800
• Other study ID #: GMO-LU-62
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 28, 2006
• Last updated: March 10, 2008
• Start date: February 2006
• Est. completion date: March 2007

Study information

• Verified date: March 2008
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Gefitinib

• Irinotecan

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate
Primary	Progression-free survival
Secondary	Overall survival
Secondary	Toxicity