UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003208 |
|---|---|
| Receipt number | R000003889 |
| Scientific Title | A feasibility study of carboplatin and irinotecan regimen in elderly patients with extensive disease small cell lung cancer. |
| Date of disclosure of the study information | 2010/02/22 |
| Last modified on | 2014/08/18 11:57:55 |
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Basic information
Public title
A feasibility study of carboplatin and irinotecan regimen in elderly patients with extensive disease small cell lung cancer.
Acronym
Caroboplatin/iritotecan regimen in elderly patients with ED-SCLC
Scientific Title
A feasibility study of carboplatin and irinotecan regimen in elderly patients with extensive disease small cell lung cancer.
Scientific Title:Acronym
Caroboplatin/iritotecan regimen in elderly patients with ED-SCLC
Region
| Japan |
Condition
Condition
elderly patients with extensive disease small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To find whether or not a carboplatin/irinotecan regimen can be recognized as an experimental arm of future phase III trial in elderly patients with extensive disease small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
feasibility
Key secondary outcomes
toxicity, response rate, 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
carboplatin
irinotecan
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria included patients with histologically or cytologically confirmed SCLC who were >/=70 years in age and had an Eastern Cooperative Oncology Group performance status (PS) of 0 to 2. Additional criteria consisted of extensive disease (ED), chemotherapy-naive, adequate organ functions [leukocyte count >/=4,000/mm3, platelet count >/=100,000/mm3, hemoglobin level >/=9.0 g/dl, AST/ALT </=2 x upper limit of normal range, total bilirubin </=1.5 mg/dl, creatinine</=1.5 mg/dl, creatinine clearance (Ccr) >/=50 ml/min, and PaO2 >/=60 mmHg, and written informed consent
Key exclusion criteria
Exclusion criteria included symptomatic pericardial or pleural effusion requiring drainage, active concomitant malignancy, senile dementia, brain metastases requiring radiotherapy, superior vena cava (SVC) syndrome requiring radiotherapy, active infection, interstitial pneumonia, diarrhea, ileus, and serious medical or psychiatric illness.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Okamoto |
Organization
Yokohama Municipal Citizen's Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa 240-8555, JAPAN
TEL
045-331-1961
hi01-okamoto@city.yokohama.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoya Hida, Yuuki Misumi |
Organization
Yokohama Municipal Citizen's Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa 240-8555, JAPAN
TEL
045-331-1961
Homepage URL
na00-hida@city.yokohama.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
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
横浜市立市民病院、国立がんセンター中央病院、国立がんセンター東病院、岐阜市民病院、癌研有明病院、静岡がんセンター
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://jjco.oxfordjournals.org/content/44/2/116.long
Number of participants that the trial has enrolled
Results
Abstract
OBJECTIVE:
The role of platinum agents plus irinotecan has been unclear for elderly patients with extensive disease small-cell lung cancer. We conducted a feasibility study to evaluate the safety and efficacy of carboplatin plus irinotecan in preparation for a planned Phase III study.
METHODS:
Based on another Phase I study, carboplatin area under the curve of four Day 1 plus irinotecan 50 mg/m(2) Days 1 and 8 every 3 weeks for four courses was administered. Patients aged ≥70 years with a performance status of 0-2 were eligible. The primary endpoint was feasibility, defined as the percentage of patients who have received three or more courses of chemotherapy. If the feasibility was ≥60% in the first 10 patients, this endpoint would be considered to be met.
RESULTS:
Eleven patients were registered. The median age was 77 years, and nine patients had a performance status of 1. Ten patients completed four courses of treatment, and neither dose omission nor modification was required. The feasibility was 91% (10/11) and the relative dose intensity was 76.9%. Because neutropenia was frequently prolonged, the next course was delayed in 53% of all courses. Other toxicities were generally mild, and the only Grade 4 toxicity was hyponatremia. The overall response rate was 90% (9/10), and the progression-free survival and the overall survival were 5.1 and 10.9 months, respectively.
CONCLUSIONS:
This regimen appears to be feasible and effective. Based on these results, a Phase II/III trial comparing carboplatin plus etoposide with carboplatin plus irinotecan for elderly patients with extensive disease small-cell lung cancer is being planned by the Japan Clinical Oncology Group.
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
| 2010 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 04 | Month | 01 | Day |
Other
Other related information
A feasibility study of carboplatin plus irinotecan treatment for elderly patients with extensive disease small-cell lung cancer. Misumi Y, Nishio M, Takahashi T, Ohyanagi F, Horiike A, Murakami H, Kenmotsu H, Yamamoto N, Ishii M, Shimokawa T, Hida N, Okamoto H. Jpn J Clin Oncol. 2014 Feb;44(2):116-21. doi: 10.1093/jjco/hyt195. Epub 2013 Dec 13.
Management information
Registered date
| 2010 | Year | 02 | Month | 18 | Day |
Last modified on
| 2014 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003889
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