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Second-Line Irinotecan or Gefitinib in Docetaxel Pretreated NSCLC

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ClinicalTrials.gov Identifier: NCT00319800
Recruitment Status : Unknown
Verified March 2008 by Gachon University Gil Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : April 27, 2006
Last Update Posted : March 12, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Gefitinib Drug: Irinotecan Phase 2

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  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2006
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Objective response rate
  2. Progression-free survival

Secondary Outcome Measures :
  1. Overall survival
  2. Toxicity


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319800


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

ClinicalTrials.gov Identifier: NCT00319800     History of Changes
Other Study ID Numbers: GMO-LU-62
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: March 12, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Irinotecan
Gefitinib
Camptothecin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Protein Kinase Inhibitors