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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate

Principal Investigator

Se Hoon Park, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gachon University Gil Medical Center, Incheon, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

GMO-LU-62

NCT ID:

NCT00319800

Start Date:

February 2006

Completion Date:

March 2007

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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