NIPH Clinical Trials Search

UMIN ID: C000000072

Registered date:22/08/2005

A combination phase I/II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedpreviously untreated elderly non-small cell lung cancer
Date of first enrollment2005/06/01
Target sample size25
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)The treatment schedule included carboplatin, diluted with 500 ml of normal saline, given intravenously over 90 minutes on day 1, and gemcitabine with 100 ml of normal saline, given intravenously over 30 minutes before the administration of carboplatin infusion on days 1 and 8, every 3 weeks.


Primary Outcometo establish MTD and to determine the RD
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum70years-old
Age maximumNot applicable
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 or ascites, acute inflammation, symptomatic brain metastases, active concurrent malignancies, severe drug allergies, severe heart disease, cerebrovascular disease, uncontrollable diabetes mellitus, severe infection.

Related Information


public contact
Name Shinichiro Nakamura
Address Japan
Telephone 06-6633-7400
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Takayasu Kurata
Address 13-70, Kitaoji-cho, Akashi City, Hyogo, Japan, 673-8558 Japan
Telephone 078-929-1151
Affiliation Hyogo Medical Center for Adults Department of Medical Oncology