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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000150
Receipt No. R000000216
Scientific Title A Phase I/II Study of Amrubicine and Irinotecan in Patients with Advanced Small Cell Lung Cancer
Date of disclosure of the study information 2005/09/09
Last modified on 2015/08/31

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Basic information
Public title A Phase I/II Study of Amrubicine and Irinotecan in Patients with Advanced Small Cell Lung Cancer
Acronym A Phase I/II Study of Amrubicine and Irinotecan in Patients with Advanced Small Cell Lung Cancer
Scientific Title A Phase I/II Study of Amrubicine and Irinotecan in Patients with Advanced Small Cell Lung Cancer
Scientific Title:Acronym A Phase I/II Study of Amrubicine and Irinotecan in Patients with Advanced Small Cell Lung Cancer
Region
Japan

Condition
Condition small cell lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Small cell lung cancer is one of most chemotherapy-sensitive malignancies. However, the outcome of systemic chemotherapy has been disappointing in extended disease small cell lung cancer (ED-SCLC). This study was conducted to test efficacy and toxicity of the combined regimen of Amrubicine and Irinotecan in ED-SCLC patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I: to determine the maximum tolerated dose and the recommended dose for phase II study
Phase II: to confirm the efficacy and toxicity of the combined therapy at the recommended dose
Key secondary outcomes

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 The Amrubicine is administered on day 1-3, and the Irinotecan is administered on day 1 and 8 every three weeks.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with histological or cytological confirmation of SCLC
2) Extended disease or Limited disease with malignant effusion
3) Patients previously untreated with chemotherapy
4) At least 2 Months of Life expectancy
5) ECOG Performance Status (PS) 0-1
6) The presence of measurable region
7) Adequate organ function
8) 20 years or older to 70 years
9) Written informed consent
Key exclusion criteria Presence of pulmonary fibrosis with symptoms or apparent abnormality on chest X-rays,
2) Acute inflammation, infection
3) Massive pleural effusion or pericardial effusion
4) Uncontrollable diabetes mellitus
5) ileus, intestinal paralysis, diarrhea
6) Symptomatic brain metastasis
7) Severe heart disease
8) Pregnancy
9) Severe drug allergies
10) Prior radiotherapy to the chest or the pelvis.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Nakanishi
Organization Kyushu University Hospital
Division name Research institute for the disease of the chest
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL 092-642-5378
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 09 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed?term=24379211
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
2003 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2004 Year 03 Month 01 Day
Last follow-up date
2008 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 09 Day
Last modified on
2015 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000216

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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