UMIN-CTR Clinical Trial

Public title

A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients

Acronym

A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients

Scientific Title

A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients

Scientific Title:Acronym

A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients

Region

Japan

Condition

Objective of the study is to investigate efficacy and safety of Erlotinib for previously treated non-small cell lung cancer patients.

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

Objective of the study is to investigate efficacy and safety of Erlotinib for previously treated non-small cell lung cancer patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Response Rate

Key secondary outcomes

Disease Control Rate,Progression Free Survival,Overall Survival,evaluation of safety

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

Erlotinib single 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

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically proven stage IIIb or IV non-small cell lung cancer.
2) Patients who have previously treated with one or two chemotherapy.
3) No prior treatment with epidermal growth factor tyrosine kinase inhibitor.
4) Patients who has at least one or more measurable lesion(s) by RECIST.
5) Performance status (ECOG) 0-2
6) Patients who can be hospitalized for at least two weeks after beginning of the treatment or under similar management.
7) Patients aged 20 years or older.
8) Sufficient function of main organ and bone marrow filled the following criteria:
Leukocyte counts, 3,000/mm3 or over -12,000/mm or less.
Neutrophil counts, 1,500/mm3 or over.
Platelets, 100,000/mm3 or over.
AST and alt, x 2 of upper limit of normal (ULN) or less.
Total bilirubin, 1.5mg/dl or less.
Serum creatinin, x 1.5 of ULN or less.
SpO2 90% or above.
9) Patients who are considered to survive for more than 3 months.
10) interval:
(1) Chemotherapy, more than 4 weeks after the last chemotherapy.
(2) Radiation, more than 12 weeks after the thoracic irradiation or more than 2 weeks after the last irradiation to other organs.
(3) Operation, more than 4 weeks after the last operation (including pleurodesis)
11) Patients providing written informed consent.

Key exclusion criteria

1) Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, or drug-induced pneumonitis.
2) Patients with massive pleural or pericardial effusion,or ascites.
3) Patients with active severe infections.
4) Cases with past history of administration of HER related agents(gefitinib,trastuzumab,lapatinib,cetuximab).
5) Impossible cases with oral administration.
6) Patients with active opthalmological disease.
7) Pregnancy or lactation.
8) Patients with symptomatic brain metastasis.
9) Patients with active concomitant malignancy.
10) Patients with uncontrollabe diabetes mellitus.
11) Patients with uncontrollable complications.
12) Inappropriate patients for this study judged by the physicians.

Target sample size

27

Name of lead principal investigator

1st name
Middle name
Last name	Eiji Shimizu

Organization

Tottori University, Faculty of Medicine

Division name

Division of Medical Oncology and Molecular Respirology Department of Multidisciplinary Internal Medicine

Zip code

Address

36-1 nishi-cho,Yonago,Tottori,683-8504,Japan

TEL

0859-38-6537

Email

Name of contact person

1st name
Middle name
Last name	Shingo Matsumoto

Organization

Tottori University, Faculty of Medicine

Division name

Division of Medical Oncology and Molecular Respirology Department of Multidisciplinary Internal Medi

Zip code

Address

36-1 nishi-cho,Yonago,Tottori,683-8504,Japan

TEL

0859-38-6537

Homepage URL

Email

watsum@grape.med.tottori-u.ac.jp

Institute

Tottori University, Faculty of Medicine,Division of Medical Oncology and Molecular Respirology Department of Multidisciplinary Internal Medicine

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

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

鳥取大学医学部附属病院、公立八鹿病院、鳥取県立中央病院、米子医療センター、山陰労災病院、済生会境港総合病院、日野病院、松江市立病院、松江医療センター、松江赤十字病院

Date of disclosure of the study information

2010

Year

12

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2009

Year

02

Month

05

Day

Date of IRB

Anticipated trial start date

2009

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

12

Month

07

Day

Last modified on

2010

Year

12

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005073