UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003539
Receipt number R000004221
Scientific Title Phase II study to investigate efficacy and safety of erlotinib in elderly patients with advanced and recurrent NSCLC
Date of disclosure of the study information 2010/04/30
Last modified on 2014/12/03 16:11:30

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Basic information

Public title

Phase II study to investigate efficacy and safety of erlotinib in elderly patients with advanced and recurrent NSCLC

Acronym

Phase II study to investigate efficacy and safety of erlotinib in elderly patients with advanced and recurrent NSCLC

Scientific Title

Phase II study to investigate efficacy and safety of erlotinib in elderly patients with advanced and recurrent NSCLC

Scientific Title:Acronym

Phase II study to investigate efficacy and safety of erlotinib in elderly patients with advanced and recurrent NSCLC

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 investigate efficacy and safety of erlotinib in elderly patients with advanced and recurrent NSCLC who previously treated with chemotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

response rate

Key secondary outcomes

Disease control rate, progression free survival, overall survival, safety profile


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

Single agent chemotherapy with 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

75 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Histologically or cytologically proven non-small cell lung cancer.
(2) Patients with recurrent non-small cell lung cancer of stage IIIB or IV after surgery who did not respond to or relapsed after prior >=2 chemothrepies.
(3) Patients aged 75 years or older.
(4) No prior treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI)
(5) Patient who has at least one or more measurable lesion by RECIST.
(6) ECOG performance status (PS): 0-1
(7) Patients who are able to receive treatment by hospitalization for at least 2 weeks or under equivalent condition
(8) Sufficient function of main organs and bone marrow filled the following criteria.
- Leukocyte count >=3000/mm3
- Neutrophil count >=1500/mm3
- Hemoglobin >=8.0g/dL
- Platelet <=100,000/mm3
- AST and ALT <=100 IU/L
- Total bilirubin <=1.5mg/dL
- Serum creatinine <=1.5mg/dL
- Sp O2 >=90%
(9) Patients who are considered to survive for more than 3 months
(10) Time from the previous treatment at the time of day 1 of the study treatment.
Chemotherapy
- >=3 weeks from the last treatment
Radiation therapy
- Irradiation to chest: >=12 weeks from the last irradiation
- Irradiation to other lesion: >=2 weeks from the last irradiation
Surgery and treatment (pleural adhesion surgery and pleural drainage)
- >=2 weeks from the surgery/last treatment
(11) Patient who signed a written informed consent

Key exclusion criteria

(1) Patients with pulmonary disorders including idiopathic pulmonary fibrosis, interstitial lung disease, pneumoconiosis, active radiation pneumonia and drug-induced pneumonia
(2) Massive pleural effusion, pericardial effusion, ascites, and superior vena cava syndrome
(3)Patients with complication with infectious disease which requires intravenous injection of antibiotic or antimycotic agent
(4) Patients who have been treated with HER drugs (gefitinib, trastuzumab, lapatinib, cetuximab)
(5) Patients who are not able to take oral medication
(6) Patients with clinically significant ophthalmologic disorder (severe eye disorders including Sjogren's syndrome, keratoconjunctivitis sicca, keratitis)
(7) Pregnant or lactating women
(8) Brain metastasis with symptoms
(9) Active multiple cancer
(10) Diabetes patients with poor disease control
(11) Patients with clinically significant complications (including cardiac disorder with poor control, severe arrhythmia requires medication, persistent watery diarrhea)
(12) Patients who are considered ineligible based on decision of a responsible investigator

Target sample size

26


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Ueoka

Organization

National Hospital Organization,Yamaguchi - Ube Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

685 Higashikiwa, Ube-City, Yamaguchi, 755-0241, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshihiko Segawa

Organization

National Hospital Organization,Yamaguchi - Ube Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

685 Higashikiwa, Ube-City, Yamaguchi, 755-0241, Japan

TEL

0836-58-2300

Homepage URL


Email



Sponsor or person

Institute

Yamaguchi Thoracic Oncology Group(YTOG)

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


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

専門病院・医院


Other administrative information

Date of disclosure of the study information

2010 Year 04 Month 30 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

Open public recruiting

Date of protocol fixation

2010 Year 02 Month 15 Day

Date of IRB


Anticipated trial start date

2010 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 04 Month 26 Day

Last modified on

2014 Year 12 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004221


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name