UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000084 |
|---|---|
| Receipt number | 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 08:34:27 |
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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
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
takiguchi@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba Lung Cancer Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000136
