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Second-Line Irinotecan or Gefitinib in Docetaxel Pretreated NSCLC

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Gachon University Gil Medical Center.
Recruitment status was  Active, not recruiting
Information provided by:
Gachon University Gil Medical Center Identifier:
First received: April 28, 2006
Last updated: March 10, 2008
Last verified: March 2008

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.

Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Gefitinib
Drug: Irinotecan
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Objective response rate
  • Progression-free survival

Secondary Outcome Measures:
  • Overall survival
  • Toxicity

Estimated Enrollment: 50
Study Start Date: February 2006
Estimated Study Completion Date: March 2007
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.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00319800

Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405 760
Sponsors and Collaborators
Gachon University Gil Medical Center
Principal Investigator: Se Hoon Park, MD Gachon University Gil Medical Center, Incheon, Korea
  More Information

No publications provided Identifier: NCT00319800     History of Changes
Other Study ID Numbers: GMO-LU-62
Study First Received: April 28, 2006
Last Updated: March 10, 2008
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on February 27, 2015