Phase II study of cisplatin, docetaxel, and irinotecan, followed by gefitinib, gemcitabine and vinorelbine for patients with non-small-cell lung cancer harboring active EGFR gene mutations (OLCSG0704)

UMIN ID: UMIN000002095

Registered date:01/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: non-small-cell lung cancer
• Date of first enrollment: 2007/12/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Cisplatin, docetaxel, (and irinotecan), followed by gefitinib, gemcitabine and vinorelbine for patients with non-small-cell lung cancer harboring active EGFR gene mutation

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Response rate, progression-free survival, adverse events, treatment compliance, relationship between response rate and expression levels of ERCC1 and thioredoxin in the tumors, Comparison of outcomes with EGFR mutation negative patients

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: Symptomatic brain metastasis, Symptomatic malignant pleural/pericardial effusion Active concomitant malignancy Unstable angina, recent myocardial infarction, heart failure Uncontrolled diabetes or hypertension Pregnant or lactating women Other severe complications

Related Information

• Primary Sponsor: Okayama Lung Cancer Study Group
• Source(s) of Monetary Support: Self funding