Second-Line Irinotecan or Gefitinib in Docetaxel Pretreated NSCLC

Gachon University Gil Medical Center

Status and phase: Unknown; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Gefitinib; Drug: Irinotecan

Study type: Interventional

Funder types: Other

Identifiers

NCT00319800

GMO-LU-62

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)