UMIN-CTR Clinical Trial

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

Non-small cell lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

YES

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

Primary outcomes

To determine the recommend dose of irinotecan and erlotinib therapy

Key secondary outcomes

1. safety
2. response rate
3. disease control rate

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

kfunai@hama-med.ac.jp

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

Email

kfunai@hama-med.ac.jp

Institute

Hamamatsu University School of Medicine, First Department of Surgery

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan

Tel

053-435-2276

Email

rinri@hama-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

06

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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