UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of Erlotinib for elderly patients previously treated non-small cell lung cancer without epidermal growth factor receptor mutation
Title of the study (Brief title)	A phase II study of Erlotinib for elderly patients previously treated non-small cell lung cancer without epidermal growth factor receptor mutation
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate efficacy and safety in elderly patients previously treated non-small cell lung cancer without epidermal growth factor receptor mutation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	desease control rate, progression-free survival, overall survival, safety

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	Erlotinib 150mg/day, oral daily
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with StageIIIB or IV who pathologically proven non-small cell lung cancer. 2)Patients who have previously treated with one or two chemotherapy. 3)No prior treatment with EGFR-TKI(erlotinib, gefitinib, ZD6474, etc.). 4)Patients with EGFR wild type 5)Possible cases with oral administration 6)Patient who has at least one or more measurable lesion by RECIST. 7)Performance Status(ECOG) 0-2 8)Patients who can be hospitalized for two weeks after beginning of the treatment or under management to apply to it. 9)Patients aged 70 years or older. 10)Sufficient function of main organ and bone marrow filled the following criteria *Leukocyte counts >= 3,000/mm3 *Neutrophil counts >= 1,500/mm3 *Platelets >= 100,000/mm3 *Hemoglobin concentration >= 9.0 g/dl *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. 11)Patients who are considered to survive for more than 3 months. 12)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) 13)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 5) Impossible cases with oral administration 6)Patients with active opthalmological disease 7)Patients with current or previous (within one year) history of gastrointestinal perforation 8)Patients with uncontrollable gastrointestinal ulceration 9)Pregnancy or lactation 10)Patients with symptomatic brain metastasis 11)Patients with active concomitant malignancy 12)Patients with uncontrollable diabetes mellitus 13)Patients with uncontrollable complications 14)Inappropriate patients for this study judged by the physicians
Target sample size	44

Research contact person
Name of lead principal investigator	Takashi Ishida
Organization	Fukushima medical University
Division name	Clinical Cancer center
Address	Hikarigaoka 1, Fukushima city
TEL	024-547-1111
Email	poroishida@gmail.com

Public contact
Name of contact person	Takashi Ishida
Organization	clinical cancer center
Division name	Pulmonary Medicine
Address	Hikarigaoka 1, Fukushima city
TEL	024-547-1111
Homepage URL
Email	poroishida@gmail.com

Sponsor
Institute	Fukushima Medical University, cancer center
Institute
Department

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)

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	2010 Year 11 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 08 Month 10 Day
Anticipated trial start date	2010 Year 03 Month 01 Day
Last follow-up date	2017 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 11 Month 15 Day
Last modified on	2018 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005411