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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name