PhaseII trial of erlotinib for elderly patients with advanced or recurrent non-small cell lung cancer

UMIN ID: UMIN000001873

Registered date:11/04/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 2009/04/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Elrotinib treatment

Outcome(s)

• Primary Outcome: Anticancer efficacy(response rate and disease control rate)
• Secondary Outcome: Progression free survival, overall survival,and safety

Key inclusion & exclusion criteria

• Age minimum: 70years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis,or drug-induced pneumonitis 2)Patients with massive pleural or pericardial effusion ,or ascites 3)Patients with active severe infections 4)Cases with past history of administration of HER related agents 5)Impossible cases with oral administration 6)Patients with active opthalmological disease 7)Patients with symptomatic brain metastasis 8)Patients with active concomitant malignancy 9)Patients with uncontrollabe diabetes mellitus 10)Patients with uncontrollable complications 11)Inappropriate patients for this study judged by the physicians

Related Information

• Primary Sponsor: Keio University School of Medicine Division of Pulmonary Medicine
• Source(s) of Monetary Support: Keio University School of Medicine Division of Pulmonary Medicine