Second-Line Irinotecan or Gefitinib in Docetaxel Pretreated NSCLC

March 10, 2008 updated by: Gachon University Gil Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of, 405 760
        • Gachon University Gil Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival
Objective response rate

Secondary Outcome Measures

Outcome Measure
Toxicity
Overall survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Investigators

  • Principal Investigator: Se Hoon Park, MD, Gachon University Gil Medical Center, Incheon, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion

March 1, 2007

Study Registration Dates

First Submitted

April 28, 2006

First Submitted That Met QC Criteria

April 28, 2006

First Posted (Estimate)

April 27, 2006

Study Record Updates

Last Update Posted (Estimate)

March 12, 2008

Last Update Submitted That Met QC Criteria

March 10, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMO-LU-62

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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