NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001780

Registered date:17/03/2009

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedNon-small cell lung cancer
Date of first enrollment2009/03/01
Target sample size57
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Erlotinib plus Docetaxel

Outcome(s)

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

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaPhase1 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

Contact

public contact
Name Shinichiro Nakamura
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN Japan
Telephone 06-6633-7400
E-mail datacenter@wjog.jp
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Shinzoh Kudoh(Tatsuo Kimura)
Address 1-4-3, Asahimachi, Abeno-ku, Osaka Japan
Telephone 06-6645-3803
E-mail
Affiliation Osaka City University Medical School Department of Respiraory Medicine