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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000813

Enrollment

Registered

2007-09-12

Start date

2007-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previously treated non-small-cell lung cancer

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (a) The diagnosis of non-small cell lung cancer was confirmed with histological or cytological examination; (b) Stage IIIB, stage IV, or relapse after operation; (c) Prior two chemotherapeutic regimens; (d) Confirmation of progressive disease, refractory disease, or relapse after prior treatment either chemotherapy or chemoradiotherapy; (e) A measurable or evaluable tumor lesion according to WHO criteria in CT or MRI performed within 4 weeks; (f) Good performance status: a performance status (PS) of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale; (g) Adequate hepatic function (serum bilirubin level<1.5 x LN, ALT and AST < 2.5 x LN); (h) Adequate renal function (serum creatinine level<1.5 x LN); (i) Adequate hematologic function (neutrophil count; equal to or more than 1,500/micro L, hemoglobin; equal to or more than 10g/dL, platelet count; equal to or more than 100,000/micro L); (j) Adequate cardiac function (cardiothoracic ratio< 55%); (k) Informed consent to receive chemotherapy and attend this study was obtained; (l) Scheduled treatment with chemotherapy and without radiotherapy; (m) Predicted prognosis equal to or more than 3 months;

Exclusion criteria

Exclusion 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

Design outcomes

Secondary

Measure	Time frame
(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	—

Primary

Measure	Time frame
Progression free survival	—

Countries

Japan

Contacts

Public ContactHiroyasu Yasuda

Kyoto University Hospital Division of Clinical Trial Design and Management, Translational Clinical Center/ Outpatient Oncology

yasuda@kuhp.kyoto-u.ac.jp075-751-4770

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026