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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000177
Receipt No. R000000241
Scientific Title PhaseI Study of Amrubicin for Previously Treated Small Cell Lung Cancer
Date of disclosure of the study information 2005/09/12
Last modified on 2018/10/03

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Basic information
Public title PhaseI Study of Amrubicin for Previously Treated Small Cell Lung Cancer
Acronym Amrubicin for Previously Treated Small Cell Lung Cancer
Scientific Title PhaseI Study of Amrubicin for Previously Treated Small Cell Lung Cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Nobuyuki Katakami
Organization Kobe City General Hospital
Division name Division of Pulmonary Medicine
Zip code
Address 4-6 Minatojima-Minamimachi Chuo-ku
TEL 078-302-4321
Email

Public contact
Name of contact person
1st name
Middle name
Last name Michio Hayashi
Organization Kobe City General Hospital
Division name Division of Pulmonary Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2004 Year 07 Month 15 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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