UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005873 |
|---|---|
| Receipt number | R000006938 |
| Scientific Title | Phase I Study of Irinotecan and Erlotinib in Patients with Erlotinib Failure for EGFR Mutations Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2011/06/29 |
| Last modified on | 2023/01/06 14:47:27 |
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Basic information
Public title
Phase I Study of Irinotecan and Erlotinib in Patients with Erlotinib Failure for EGFR Mutations Non-Small Cell Lung Cancer
Acronym
Phase I Study of Irinotecan and Erlotinib in Patients with Erlotinib Failure for EGFR Mutations Non-Small Cell Lung Cancer
Scientific Title
Phase I Study of Irinotecan and Erlotinib in Patients with Erlotinib Failure for EGFR Mutations Non-Small Cell Lung Cancer
Scientific Title:Acronym
Phase I Study of Irinotecan and Erlotinib in Patients with Erlotinib Failure for EGFR Mutations Non-Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigeate the safety and efficacy of irinotecan and erlotinib therapy for Erlotinib Failure for EGFR Mutations Non-Small Cell Lung Cancer.
Basic objectives2
Others
Basic objectives -Others
To determine the recommend dose of irinotecan and erlotinib therapy
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
To determine the recommend dose of irinotecan and erlotinib therapy
Key secondary outcomes
1. safety
2. response rate
3. disease control rate
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
Irinotecan and Erlotinib therapy
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Stage IIIB/IV non-small cell lung cancer proven by histology and post-operative recurrent disease.
2)Two prior systemic chemotherapy regimens.
3)Erlotinib treatment is done for three weeks or more, interstitial pneumonia is not admitted, and effect of SD or more.
4)Possible cases with oral administration.
5)No prior treatment with irinotecan.
6)Diagnosed no mutation or heterozygosity of UGT1A1*6/*28
7)EGFR mutations in the tumor specimens.
8)Measurable lesion by RECIST.
9)ECOG Performance status(PS) of 0-1.
10)A life expectancy of more than 3 months.
11)No severe impairment of major organs (bone marrow, heart, lungs, liver, kidneys, etc.),
laboratory data within 14 days
WBC >=3,000/mm3 and <=12,000mm3
neutrophil >=1,500/mm3
platelet >=100,000/mm3
hemoglobin >=8.0g/dL
AST and ALT <=2.5 ULN
T-Bil <=1.5 ULN
Cr <=ULN
SpO2(Room air)>=92%
12)Written informed consent.
Key exclusion criteria
1)Diagnosed mutation or heterozygosity of UGT1A1*6/*28.
2)Serious drug allergy.
3)Interstitial pneumonia documented obviously in chest X ray.
4)massive pleural or pericardial effusion ,or ascites.
5)active severe infections.
6)Active synchronous malignancies.
7)Pregnant or beeast-feeding woman or patient who doesn't agree to contraception.
8)Serious psychological disease.
9)brain metastasis.
10)Clinically significant heart disease (myocardial infarction within 12 months, etc.).
11)Uncontrolled diabetes mellitus.
12)Watery diarrhea.
13)Ileus or bowel obstruction.
14)bleeding that requires medication or transfusion.
15)Clinically significant complication.
16)Investigator's judgement.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | kazuhito |
| Middle name | |
| Last name | Funai |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
431-3192
Address
1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan
TEL
053-435-2276
kfunai@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | kazuhito |
| Middle name | |
| Last name | Funai |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
431-3192
Address
1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan
TEL
053-435-2276
Homepage URL
https://www.hama-med.ac.jp/hos/departments/thoracic-surg/index.html
kfunai@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine, First Department of Surgery
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
Tel
053-435-2276
rinri@hama-med.ac.jp
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
| 2011 | Year | 06 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
1
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
Terminated
Date of protocol fixation
| 2011 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2010 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 29 | Day |
Last modified on
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006938
