Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments gefitinib, irinotecan
Phase phase 2
Target EGFR
Sponsor Gachon University Gil Medical Center
Start date February 2006
End date March 2007
Trial size 50 participants
Trial identifier NCT00319800, GMO-LU-62

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Objective response rate
time frame:
Progression-free survival
time frame:

Secondary Outcomes

Measure
Overall survival
time frame:
Toxicity
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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
Principal investigator Se Hoon Park, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2008.
Information provided to ClinicalTrials.gov by Gachon University Gil Medical Center.