UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PhaseI Study of Amrubicin for Previously Treated Small Cell Lung Cancer
Title of the study (Brief title)	Amrubicin for Previously Treated Small Cell Lung Cancer
Region	Japan

Condition
Condition	For patients with recurrent or relapsed small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine maximum tolerated dose (MTD), dose-limiting toxicity (DLT) and recommended dose (RD) of amrubicin for patients with recurrent or relapsed small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Feasibility (estimation of MTD,DLT and RD)
Key secondary outcomes	Effectiveness (anti-tumor effect of amrubicin with recommended dose)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	74 years-old >=
Gender	Male and Female
Key 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 < 12000/mm3, Granulocyte count > 2000/mm3, Platelet count > 12000/mm3, Hb > 9.5 g/dl 2.Hepatic: AST & ALT < * 2.5 upper normal limit, Total bilirubin < 1.5mg/dl 3.Renal: Serum creatinine < upper normal limit 4.Pulmonary: PaO2 > 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.
Key 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.
Target sample size	18

Research contact person
Name of lead principal investigator	Nobuyuki Katakami
Organization	Kobe City General Hospital
Division name	Division of Pulmonary Medicine
Address	4-6 Minatojima-Minamimachi Chuo-ku
TEL	078-302-4321
Email

Public contact
Name of contact person	Michio Hayashi
Organization	Kobe City General Hospital
Division name	Division of Pulmonary Medicine
Address	4-6 Minatojima-Minamimachi Chuo-ku
TEL	078-302-4321
Homepage URL
Email	katakami@kcgh.gr.jp

Sponsor
Institute	Kobe City General Hospital
Institute
Department

Funding Source
Organization	no
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Institute of Biomedical Research and Innovation Kobe City West Hospital Nishikobe Medical Center
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2005 Year 09 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2004 Year 07 Month 15 Day
Anticipated trial start date	2004 Year 11 Month 01 Day
Last follow-up date	2007 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2005 Year 09 Month 12 Day
Last modified on	2018 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000241