Phase I/II study of intermittent erlotinib in combination with docetaxel in patients with recurrent non-small cell lung cancer

UMIN ID: UMIN000001780

Registered date:17/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 2009/03/01
• Target sample size: 57
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Erlotinib plus Docetaxel

Outcome(s)

• Primary Outcome: Phase I study:Safety Determine recommended dose Phase II study: Response rate
• Secondary Outcome: Safety Disease control rate Progression free survival Overall survival 1 year survival rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Phase1 1)Previous treatment with an agent of which the main mechanism of action is inhibition of EGFR families or its associated tyrosine kinase 2)Previously received docetaxel 3)Obvious pulmonary interstitial abnormality on chest CT 4)Uncontrolled infections or uncontrolled serious systematic disease 5)symptomatic brain metastasis 6)Other co-existing malignancies or malignancies diagnosed within the last 5 years 7)significant pleural effusion, pericardial effusions or ascites, 8)patient who cannot eat enough 9)severe drug allergies 10)Hypersensitive to polysorbate80 11)Pregnant or breast feeding 12)HBs-Ag positive or HCV-Ab positive 13)Patient for whom this clinical trial is judged to be inappropriate by physicians Phase2 1)Previous treatment with an agent of which the main mechanism of action is inhibition of EGFR families or its associated tyrosine kinase 2)Previously received docetaxel 3)Obvious pulmonary interstitial abnormality on chest CT 4)Uncontrolled significant active infections or uncontrolled systematic disease 5)symptomatic brain metastasis 6)Other co-existing malignancies or malignancies diagnosed within the last 5 years 7)significant pleural effusion, pericardial effusions or ascites, 8)patient who cannot eat enough 9)severe drug allergies 10)Hypersensitive to polysorbate80 11)Pregnant or breast feeding 12)HBs-Ag positive or HCV-Ab positive 13)Patient for whom this clinical trial is judged to be inappropriate by physicians

Related Information

• Primary Sponsor: West Japan Oncology Group
• Source(s) of Monetary Support: None