small-cell lung cancer
Conditions
Interventions
Amrubicin hydrochloride is intravenously administered for 3 consecutive days every 3 weeks. Three weeks comprise one course of treatment, and subjects receive 2 or more courses but a maximum of 4 cour
Sponsors
Lung Oncology Group in Kyushu, Japan (LOGIK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1)Histological or cytological diagnosis of lung cancer (2)Clinical stage IIIB (not indicated for radical radiotherapy) or IV (3)Previously treated with one regimen of chemotherapy for small-cell lung cancer (including intrathoracic administration of an anticancer drug) (4)At least 28 days have passed since the final dose of the prior chemotherapy(5)Have not undergone surgery or thoracic radiotherapy within 28 days prior to enrollment (i.e., 28 days counting from the day of final irradiation as day 0) (6)Have measurable lesions according to the RECIST criteria (minimally 20 mm measured by CT scan with 10-mm slice thickness, or 10 mm by CT scan with 5-mm slice thickness; lesions in an irradiated area are not considered measurable) (7)Age 70 years or older (at consent) (8)ECOG Performance Status (PS) 0 or 1 (9)Have adequate function of major organs (bone marrow, liver, kidneys, lungs, and heart) defined as follows:White blood cells>=4,000/mm3 or <=12,000/mm3 Neutrophils>=2,000 /mm3 Platelets>=100,000 /mm3 Hemoglobin>=10 g/dL AST and ALT<=2.5 times ULN for the medical institution Serum total bilirubin<=1.5 mg/dL Serum creatinine<=1.5 times ULN for the medical institution PaO2>=65mmHg LVEF (echocardiography)>=60% ECG: No abnormal findings requiring treatment (10)Provided written consent in person for participation in this study
Exclusion criteria
Exclusion criteria: (1)Previously treated with amrubicin hydrochloride (2)Interstitial pneumonia or pulmonary fibrosis suspected on chest CT (3)Abnormal cardiac function, myocardial infarction, or history thereof (4)Received the maximum allowed cumulative dose* of cardiotoxic drugs such as anthracycline derivatives in prior therapy *Maximum allowed cumulative doses are 25 mg/kg (body weight) for daunorubicin hydrochloride, 500 mg/m2 (body surface area) for doxorubicin hydrochloride, 900 mg/m2 for epirubicin hydrochloride, and 950 mg/m2 for pirarubicin hydrochloride (5)Symptomatic brain metastases (6)Pleural effusion, ascites, or pericardial effusion requiring drainage(7)Serious complications (cancerous pericarditis, superior vena cava syndrome, serious infection) (8)History of drug allergy judged unacceptable for participation in the study (9)Pregnant, possibly pregnant, or desire to become pregnant (10)For other reasons judged by the investigator (principal investigator or subinvestigator) to be inappropriate for this study (11)Active multiple cancers treated within the past 5 years as of the day of enrollment or during treatment with amrubicin hydrochloride (12)Uncontrolled diabetes mellitus, chronic steroid use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: Estimation of the DLT and MTD, determination of the RD, assessment of adverse events. severity of adverse events is assessed according to the "Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0."Phase 2: Response rate (CR + PR) Tumor response is assessed according to the "Response Evaluation Criteria in Solid Tumors (the RECIST criteria)." | — |
Countries
Japan
Contacts
Public ContactKoichi Takayama
Kyushu University, Graduate School of Medical Sciences Research Institute for Diseases of the Chest
Outcome results
None listed