NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000002465

Registered date:07/09/2009

A phase II trial of ifosphamide for patients with previously treated small cell lung cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedpreviously treated small cell lung cancer
Date of first enrollment2009/07/01
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Ifosphamide

Outcome(s)

Primary OutcomeResponse rate
Secondary OutcomeProgression free survival median survival time Safety(incidence of adverse event)

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria1 Histologically or cytologically proven small-cell lung cancer 2 Age between 20 and 75 years 3 Have measurable lesions as defined by RECIST 4 Confirmation of progressive disease, refractory disease, or relapse after first chemotherapy(both limited and extensive stage) 5 Prior one more chemotherapeutic regimen 6 At least 4 weeks must have elapsed since radiotherapy 7 Adequate organ functions Neutrophil count>=1500/mm3 Platelet count>=100,000/mm3 Hemoglobin>=9.0g/dl Serum creatinine<=1.5mg/dl Serum bilirubin<=1.5mg/dl AST/ALT<=100mg/dl 8 ECG: no abnormality needed therapy 9 Performance status(ECOG)0-2 10 Life expectancy more than 12 weeks 11 Written informed consent
Exclude criteria1 severe pleural, pericardial effusion, ascites or supra vena cava syndrome 2 sever complication(severe cardiac disease, heart failure, myocardial infarction and angina pectoris within the last 6 months, cerebrovascular disease within the last 6 months, poorly controlled hypertension, active infection)and another active cancer 3 symptomatic brain metastases 4 pregnancy, intent to became pregnant,or breast-feeding 5 active psychological disease 6 non eligible cases judged by investigators

Related Information

Contact

public contact
Name Ichidai Tanaka
Address 65 Tsurumai-cho, Showa-ku, Nagoya Japan
Telephone 052-744-2167
E-mail ichidai1104@hotmail.co.jp
Affiliation Nagoya University Graduate School of Medicine respiratory medicine
scientific contact
Name Yoshinori Hasegawa
Address 65 turumai-tyo showa-ku nagoya-sia-ku nagoya-si Japan
Telephone 052-481-5111
E-mail yhasega@med.nagoya-u.ac.jp
Affiliation Nagoya University Hospital respiratory medicine