NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001820

Registered date:31/03/2009

Single Arm Phase II Trial of Nitroglycerin Plus Docetaxel in Elderly Untreated Stage IIIB/IV Non-small-cell Lung Cancer

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedNon-small-cell lung cancer
Date of first enrollment2009/03/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Transdermally applied nitroglycerin (10 mg/day) for consecutive 5 days between 3 days before start of chemotherapy using 60 mg/m2 of docetaxel (D1) every 3 weeks and the day 2 of chemotherapy

Outcome(s)

Primary Outcome(1) response rate
Secondary Outcome(1) Progression free survival (2) Frequency of toxicities (3) Overall survival (4) Change in plasma vascular endothelial growth factor level during nitroglycerin treatment for 3 days before chemotherapy as an indicator for response to nitroglycerin plus docetaxel and cisplatin regimen

Key inclusion & exclusion criteria

Age minimum70years-old
Age maximum85years-old
GenderMale and Female
Include criteria
Exclude criteria(a) No treatment with a vasodilator such as calcium channel blockers (b) No prior chemotherapy or radiotherapy; (c) Without uncontrollable brain metastasis; (d) No ischemic heart disease; (e) Without active interstitial pneumonitis (f) Without uncontrollable massive pleural effusion or pericardial effusion (g) Without pregnancy or nurse (h) No enrollment in another interventional study

Related Information

Contact

public contact
Name Hiroyasu Yasuda
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan Japan
Telephone 022-717-7122
E-mail yasuda@trc.med.tohoku.ac.jp
Affiliation Tohoku University Translational Research Center Department of clinical application
scientific contact
Name Hiroyasu Yasuda
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan Japan
Telephone 022-717-7122
E-mail
Affiliation Tohoku University Translational Research Center Department of clinical application