UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000150
Receipt number 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 15:51:13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

West Japan Oncology Group

Institute

Department

Personal name



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

Value
https://center6.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