NIPH Clinical Trials Search

UMIN ID: C000000071

Registered date:22/08/2005

Phase II Study of Amrubicin in Patients with Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedAll patients had histologocally or cytologically confirmed locally advanced (non-irradiated) or metastatic NSCLC, with failure of platinum-based chemotherapy (exception for UFT and gefitinib).
Date of first enrollment2005/02/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Amrubicin was given at 40mg/m2 intravenously over 5 minutes for three consecutive days, every 3 weeks


Primary OutcomeOverall response rate (according to RECIST criteria)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteriaThe exclusion criteria consisted of pulmonary fibrosis or interstitial pneumonitis with symptoms or apparent abnormalities on chest X-ray, massive pleural effusion, pericardial effusion, or ascites, pregnancy, lactation, symptomatic brain metastases, active concurrent malignancies, severe drug allergies, myocardial infarction, severe heart disease, severe superior vena cava syndrome, uncontrollable diabetes mellitus, severe infection, or active peptic ulcer. Patients who have prior receive amrubicin and other anthracycline drugs were excluded, too.

Related Information


public contact
Name Shinichiro Nakamura
Address Japan
Telephone 06-6633-7400
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Hisao Uejima
Address 2-23 Rinkuoraikita, Izumisano, Osaka, 598-0048, Japan Japan
Affiliation Izumisano Municipal Hospital, Rinku General Medical Center Department of Respiratory Medicine