Second-Line Irinotecan or Gefitinib in Docetaxel Pretreated NSCLC
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ClinicalTrials.gov Identifier: NCT00319800
Verified March 2008 by Gachon University Gil Medical Center. Recruitment status was: Active, not recruiting
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
Non-Small Cell Lung Cancer
Drug: GefitinibDrug: Irinotecan
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.
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
Estimated Study Completion Date
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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