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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000084
Receipt No. R000000136
Scientific Title Second line chemotherapy consisting of weekly irinotecan and cisplatin for relapsed/first line resistant non-small cell lung carcinoma - phase II study
Date of disclosure of the study information 2005/09/01
Last modified on 2009/08/31

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Basic information
Public title Second line chemotherapy consisting of weekly irinotecan and cisplatin for relapsed/first line resistant non-small cell lung carcinoma - phase II study
Acronym Second line chemotherapy consisting of weekly irinotecan and cisplatin for relapsed/first line resistant non-small cell lung carcinoma - phase II study
Scientific Title Second line chemotherapy consisting of weekly irinotecan and cisplatin for relapsed/first line resistant non-small cell lung carcinoma - phase II study
Scientific Title:Acronym Second line chemotherapy consisting of weekly irinotecan and cisplatin for relapsed/first line resistant non-small cell lung carcinoma - phase II study
Region
Japan

Condition
Condition Non-small-cell lung carcinoma
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical relevance of weekly irinotecan and cisplatin for patients with relapsed and/or first line chemotherapy resistant non-small-cell lung carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate (6 weeks interval for confirming SD)
Key secondary outcomes Toxicity
Survival

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 Chemotherapy
CPT-11 (60 mg/m2, weekly)
CDDP (25 mg/mg2, weekly)
at leaset 6 courses
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
15 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Histologically/cytologically proven non-small-cell lung cancer
2) Prior chemotherapy of single regimen chemotherapy
3) Resistant to first line chemotherapy or relapsed after the chemotherapy
4) PS (ECOG); 0 - 2
5) Age ranging from 15 to 74
6) Preserved organ functions as
a) WBC >= 3,000/mm3, neutrophile >= 2,000/mm3, Hb >= 9.0 g/dl, Plt >= 100,000/mm3
b) T. Bil <= 1.5 mg/dl, AST/ALT < 2 x upper limit of the normal value
c) Creatinine <= 1.5 mg/dl, Creatinine crearance >= 40 ml/min
d) PaO2 >= 70 torr
7) Measurable lesions by RECIST
8) Life expectancy for more than 8 weeks
9) Written informed consent
Key exclusion criteria 1) Prior chemotherapy including irinotecan
2) Prior chemotherapy by 2 or more chemotherapeutic regimens
3) Prior resection
4) Requirement of thoracic irradiation
5) Any contraindication for irinotecan, such as interstitial pneumonitis
6) Pleural effusion/ascites requiring treatment
7) Pericardial effusion
8) Serious concomitant medical conditions, including uncontrolled diabetes mellitus, angina pectoris, myocardial infarction within 3 months, and others
9) Brain metastasis requiring treatment
10) Concomitant malignancy
11) History of serious drug allergy
12) Pregnancy, potential pregnancy, or breast feeding
13) Others
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takiguchi, Yuichi
Organization Chiba University
Division name Department of Respirology (B2)
Zip code
Address 1-8-1, Inohana, Chuo-Ku, Chiba, Japan
TEL 043-226-2577
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takiguchi, Yuichi
Organization Chiba University
Division name Department of Respirology (B2)
Zip code
Address 1-8-1, Inohana, Chuo-Ku, Chiba, Japan
TEL 043-226-2577
Homepage URL
Email takiguchi@faculty.chiba-u.jp

Sponsor
Institute Chiba Lung Cancer Study Group
Institute
Department

Funding Source
Organization Chiba Lung Cancer Study Group
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 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Even with the standard first-line chemotherapy, advanced non-small cell lung cancer (NSCLC) recurs in most cases.  The purpose of this study is to develop a new chemotherapeutic regimen for patients with NSCLC that has relapsed or was refractory to previous chemotherapy.  Patients with proven NSCLC refractory or recurrent after previous single-regimen chemotherapy, PS of 0 to 2, age of 15 years or older, adequate organ functions and measurable lesions were treated with irinotecan at 60 mg/m2 and cisplatin at 25 mg/m2 with 1,000 ml hydration on day 1.  This administration, considered as one cycle, was repeated every week without rest unless encountering defined skip and dose-reduction criteria.  The treatment was administered for 6 cycles over a 49-day period, both median values, to 48 patients, with a response rate of 26%, progression free and median survival times of 3 and 11 months, respectively, and a 1-year survival rate of 46%.  The most frequent grade 3 or 4 toxicities were neutropenia, anaemia and nausea, which were manageable.  Subset analyses suggested that the response rate was independent of response to the first-line chemotherapy.  In conclusion, second-line chemotherapy of weekly irinotecan and cisplatin with minimum hydration seemed effective, with tolerable toxicity, and is potentially useful irrespective of the outcome of previous chemotherapy.
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
2001 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2001 Year 10 Month 01 Day
Last follow-up date
2006 Year 12 Month 01 Day
Date of closure to data entry
2007 Year 01 Month 01 Day
Date trial data considered complete
2007 Year 01 Month 01 Day
Date analysis concluded
2007 Year 03 Month 01 Day

Other
Other related information Takiguchi Y, Moriya T, Asaka-Amano Y, Kawashima T, Kurosu K, Tada Y, Nagao K, Kuriyama T. Phase II study of weekly irinotecan and cisplatin for refractory or recurrent non-small cell lung cancer. Lung Cancer 2007; 58: 253-259.

Management information
Registered date
2005 Year 08 Month 29 Day
Last modified on
2009 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=R000000136

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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