NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000002306

Registered date:07/08/2009

Phase II study of amrubicin for non-small lung cancer after failure of two or three prior chemotherapy regimens

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedNSCLC after failure of two or three prior chemotherapy regimes
Date of first enrollment2009/08/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Amrubicin 35mg/m2 is administered from day 1 to day 3

Outcome(s)

Primary OutcomeDisease control rate
Secondary OutcomeOverall survival, Progression-free survival, Objective response rate, Safety

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1)Drug allergy career with inappropriateness for participation to this study 2)Infectious disease or fever of >= 38 degrees Celsius that interferes to this treatment 3)Using oral steroid or immunosuppressive drug 4)Serious medical complications (severe heart disease/cerebrovascular disorder, severe hypertension, active digestive ulcer, uncontrolled diabetes mellitus etc.) 5)Interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray film or CT scan 6)Previous amrubicin use 7)Exceeding critical dosage in prior treatment by the drug with cardiac toxicity such as anthracycline drugs 8)Requirement of emergent therapy for pleural effusion, ascites, and pericardial effusion 9)Symptomatic brain metastasis 10)Concomitant malignancy 11)Heart disease that becomes obstacle for this sutdy 12)Psychological/mental illness that becomes obstacle for participation to this sutdy inappropriateness for participation to this study 13)Pregnant, milk-feeding, possibility becoming pregnant female 14)Other clinical inappropriateness to this study

Related Information

Contact

public contact
Name Toshiyuki Harada
Address 3-18, 1-8, Nakanoshima, Toyohira-ku, Sapporo Japan
Telephone 011-831-5151
E-mail t-harada@hok-shaho-hsp.jp
Affiliation Hokkaido Social Insurance Hospital Center of Respiratory Diseases
scientific contact
Name Toshiyuki Harada
Address 3-18, 1-8, Nakanoshima, Toyohira-ku, Sapporo Japan
Telephone 011-831-5151
E-mail
Affiliation Hokkaido Social Insurance Hospital Center of Respiratory Diseases