Phase II Study of Amrubicin and Nitroglycerin in Third-Line Chemotherapy in Previously Treated Patients with Non-Small-Cell Lung Cancer

UMIN ID: UMIN000000813

Registered date:12/09/2007

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Previously treated non-small-cell lung cancer
• Date of first enrollment: 2007/09/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Transdermally applied nitroglycerin, 10 mg/day, for consecutive 5 days between before the start of chemotherapy using 36 mg/m2 of amrubicin, D1-3, every 4 weeks and the day 2 of chemotherapy

Outcome(s)

• Primary Outcome: Progression free survival
• Secondary Outcome: (1) response rate (2) disease control rate (3) Frequency of toxicities (4) Overall survival (5) 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: 40years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (a) No treatment with a vasodilator such as calcium channel blockers; (b) No treatment with nitric oxide donationg drugs; (c) No prior chemotherapy using amrubicin; (d) No radiotherapy to evaluable tumor lesions during this protocol treatment (e) Without brain metastasis; (f) No unstable ischemic heart disease; (g) No active hepatitis; (h) No active interstitial pneumonitis; (i) No active hematological disease such as leukemia; (j) No incurable duplicative cancers; (k) No uncontrollable psychological disease; (l) No female under nursing or pregnancy (m) No enrollment in another interventional study

Related Information

• Primary Sponsor: Division of Clinical Trial Design and Management, Translational Clinical Center, Kyoto University Hospital
• Secondary Sponsor: Tohoku Univ. Hospital, Jikei Univ. Hospital, Jyuntendo Univ. Hospital, Showa Univ. Hospital, National Cancer Center Hospital East, Shinshu Univ. Hospital, Kumamoto Univ. Hospital, etc
• Source(s) of Monetary Support: Ministry of Education, Science and Culture (19689018, and 17790524) of the Japanese government