PhaseI Study of Amrubicin for Previously Treated Small Cell Lung Cancer
- Conditions
- For patients with recurrent or relapsed small cell lung cancer
- Registration Number
- JPRN-C000000177
- Lead Sponsor
- Kobe City General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility (estimation of MTD,DLT and RD)
- Secondary Outcome Measures
Name Time Method Effectiveness (anti-tumor effect of amrubicin with recommended dose)