Non-Small Cell Lung Cancer
Conditions
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.
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.
Interventions
DRUGGefitinib
DRUGIrinotecan
Sponsors
Gachon University Gil Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | — |
| Toxicity | — |
Countries
South Korea
Outcome results
None listed