For patients with recurrent or relapsed small cell lung cancer
Conditions
Interventions
Amurubicin is administered intravenously from day 1 to 3. The treatment is repeated every 3 weeks. G-CSF was routinely given once a day from day 8. The administration of G-CSF continues up to 7 days b
Sponsors
Kobe City General Hospital
Institute of Biomedical Research and Innovation Kobe City West Hospital Nishikobe Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed small cell lung cancer. 2.Previous treatment with two regimens is allowed. Prior regimen should include one drug among platinum, VP-16, CPT-11 and topotecan. 3.At least 28 days interval from the last administration of previous chemotherapy. 4.At least 28 days interval from the last delivery of irradiation to any organs (except thorax and pelvis) for palliation. 5.Life-expectancy is more than 2 months. 6.PS 0-1(ECOG). 7.Patients who have measurable lesions with RECIST criteria. 8.Adequate organ functions (bone marrow, liver, heart, lung, kidney etc.). Patients are required to satisfy all of the next-mentioned criteria: 1.Hematological: WBC > 4000/mm3 and 2000/mm3, Platelet count > 12000/mm3, Hb > 9.5 g/dl 2.Hepatic: AST & ALT 60 Torr , %VC >50% , %FEV1.0 > 60% 5.Cardiac: Ejection fraction > 60% is needed (estimated by echocardiography) 9.Age 20 to 74 years. 10.Written informed consent prior to the enrollment of the study.
Exclusion criteria
Exclusion criteria: Patients are excluded from the study if they belong to any of the following categories. 1.Serious medical co-morbidities. 1)Interstitial pneumonia or pulmonary fibrosis is recognized by plain chest X-ray film. 2)Active infectious diseases. 3)Pleural effusion, ascites or pericardial effusion requiring tube drainage. 4)Uncontrolled diabetics. 5)diarrhea (watery),intestinal.paralysis or obstructive bowel diseases. 6)Any comorbidities which seem to severely interrupt the planed treatment. 2.A symptomatic brain metastasis. 3.Patients with an impaired heart function. 4.Pregnant or lactating women. Patients who have a possibility of pregnancy. 5.Severe hypersensitivity for any drug in the past. 6.Previous radiotherapy to more than two sites. * Prophylactic cranial irradiation is not included. * Whole brain irradiation for apparent brain metastasis is considered as one prior radiotherapy. * In case of previous radiation to vertebra and/or shaft bone, up to 2 sites are permitted (i.e. Th3 + Th4, Th3 + femur, femur + humerus). * In case of previous radiation to pelvis or thorax, history of radiotherapy to any other site is not permitted. 7.A case judged to be unsuitable for enrollment of the study. 8.Previous administration of anthracyclin or its analogues. 9.Patients who are suffered from active double cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility (estimation of MTD,DLT and RD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness (anti-tumor effect of amrubicin with recommended dose) | — |
Countries
Japan
Contacts
Public ContactMichio Hayashi
Kobe City General Hospital Division of Pulmonary Medicine
Outcome results
None listed