Second-Line Irinotecan or Gefitinib in Docetaxel Pretreated NSCLC
This trial is active, not recruiting.
|Condition||non-small cell lung cancer|
|Sponsor||Gachon University Gil Medical Center|
|Start date||February 2006|
|End date||March 2007|
|Trial size||50 participants|
|Trial identifier||NCT00319800, GMO-LU-62|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Objective response rate
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
|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.|
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