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

UMIN ID: UMIN000001820

Registered date:31/03/2009

Basic Information

• Health condition(s) or Problem(s) studied: Non-small-cell lung cancer
• Date of first enrollment: 2009/03/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• 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 minimum: 70years-old
• Age maximum: 85years-old
• Gender: Male and Female
• 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

• Primary Sponsor: Tohoku University Translational Research Center
• Secondary Sponsor: Tohoku University Hospital, Shinshu University Hospital, Shiga Medical Center for Adults, Kyoto University Hospital, Osaka Police Hospital, Takatsuki Red Cross Hospital
• Source(s) of Monetary Support: Ministry of Education, Science and Culture (19689018, and 17790524) of the Japanese government, and The Kanae Foundation for the Promotion of Medical Science