UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005181 |
|---|---|
| Receipt number | R000006061 |
| Scientific Title | Phase I/II study of Irinotecan and Erlotinib in patients for EGFR mutation negative previously treated non-small-cell lung cancer. |
| Date of disclosure of the study information | 2011/03/03 |
| Last modified on | 2015/09/03 09:55:25 |
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Basic information
Public title
Phase I/II study of Irinotecan and Erlotinib in patients for EGFR mutation negative previously treated non-small-cell lung cancer.
Acronym
Phase I/II study of Irinotecan and Erlotinib in patients for EGFR mutation negative previously treated non-small-cell lung cancer.(OULCSG-1101)
Scientific Title
Phase I/II study of Irinotecan and Erlotinib in patients for EGFR mutation negative previously treated non-small-cell lung cancer.
Scientific Title:Acronym
Phase I/II study of Irinotecan and Erlotinib in patients for EGFR mutation negative previously treated non-small-cell lung cancer.(OULCSG-1101)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine the recommend dose of irinotecan and erlotinib therapy, and to investigate the safety and efficacy of the recommend dose for EGFR mutation negative previously treated non-small-cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
PhaseI:determine the recommend dose of irinotecan and erlotinib therapy
PhaseII:response rate
Key secondary outcomes
Phase I
(1)safety
(2)pharmacokinetics
(3)response rate
PhaseII
(1)safety
(2)disease control rate
(3)overall survival(OS)
(4)progression-free survival(PFS)
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
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/or
cytology.
(2)previously chemotherapy treated.
(3)Possible cases with oral
administration.
(4)No prior treatment with TKI or Mab
which affect to HER family.
(5)No prior treatment with irinotecan.
(6)Diagnosed no mutation or
heterozygosity of UGT1A1*6/*28
(7)Those without any active 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 <=UNL
SpO2(Room air)>=92%
(12)Interval from previous treatment, of
following, at enrollment;
1)Equal or more than 4 weeks after
completion of previous chemotherapy
2)Equal or more than 12 weeks after
completion of thoracic irradiation. /
Equal or more than 2 week after
completion of irradiation except for
thoracic irradiation
3)Equal or more than 4 weeks after
surgical intervention.
(13)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
27
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Imamura |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Respiratory Medicine
Zip code
Address
3-3, Nakamichi 1-chome, Higashinari-ku, Osaka 537-8511, Japan
TEL
06-6972-1181
imamura-fu@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kijima |
Organization
Osaka Univ.Hospital
Division name
Respiratory Medicine
Zip code
Address
2-15 Yamada-oka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3833
Homepage URL
tkijima@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka Univ. Hospital Respiratory Medicine
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
Osaka university lung cancer study group
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
| 2011 | Year | 03 | Month | 03 | 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
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 | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 03 | Day |
Last modified on
| 2015 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006061
