PhaseI Study of Amrubicin for Previously Treated Small Cell Lung Cancer

UMIN ID: C000000177

Registered date:12/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: For patients with recurrent or relapsed small cell lung cancer
• Date of first enrollment: 2004/11/01
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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 before the next chemotherapy. Starting dose (step 1) of amurubicin is 35mg/m2.Step 2 is 40mg/m2 and step 3 is 45mg/m2.

Outcome(s)

• Primary Outcome: Feasibility (estimation of MTD,DLT and RD)
• Secondary Outcome: Effectiveness (anti-tumor effect of amrubicin with recommended dose)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 74years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Kobe City General Hospital
• Secondary Sponsor: Institute of Biomedical Research and Innovation Kobe City West Hospital Nishikobe Medical Center
• Source(s) of Monetary Support: no