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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002735
Receipt No. R000003328
Scientific Title A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients
Date of disclosure of the study information 2009/11/11
Last modified on 2014/04/01

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Basic information
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
Condition Non-Small Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
Primary outcomes rseponse rate
Key secondary outcomes disease control rate, progression free survival, overall survival, evaluation of 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 single chemotherapy
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

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 3 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 3 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
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 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihito Yokoyama
Organization Kochi University, School of Medicine
Division name Department of Hematology and Respiratory Medicine
Zip code
Address Kohasu, Okocho, Nankoku city, Kochi, 783-8505, Japan
TEL 088-880-2345
Email im25@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Kubota
Organization Kochi University, School of Medicine
Division name Department of Hematology and Respiratory Medicine
Zip code
Address Kohasu, Okocho, Nankoku city, Kochi, 783-8505, Japan
TEL 088-880-2345
Homepage URL
Email im25@kochi-u.ac.jp

Sponsor
Institute Kochi University, School of Medicine, Department of Hematology and Resporatory Medicine
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)

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 高知大学医学部付属病院(高知県)、高知医療センター(高知県)、国立病院機構高知病院(高知県)、高知赤十字病院(高知県)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://file.scirp.org/Html/2-2560032_42972.htm
Number of participants that the trial has enrolled
Results
9th JSMO annual meeting  2011
[Purpose] To evaluate the efficacy and safety of erlotinib in patients with previously treated non-small cell lung cancer (NSCLC), a phase II trial was studied in Kochi prefecture.[Patients and methods] Patients with stage IIIB/IV NSCLC and performance status 2 or lower, previously treated with 1 or 2 non- EGFR-TKI regimens were eligible. The enrollment has started since august 2009. Patients received Erlotinib (150mg/day) until disease progression or intolerable toxicity. Primary end point was the response rate (RR). In addition, disease control rate (DCR), progression free survival (PFS), and safety were evaluated.[Results] Thirty eight patients were enrolled, and 32 patients were evaluated. Median age was 69 years (range, 57 years to 80 years). Characteristics of patients were as follows: men/women, 21/11; PS0/1/2, 11/16/5; adenocarcinoma/ non-adenocarcinoma, 23/9. The objective RR and DCR were 31% and 65%, respectively. Twenty one patients could be evaluated for EGFR status (9 mutated/ 11 wild type). The RR of EGFR mutated patients was 67%, while wild type 17%. PFS of 24 cases were evaluated as 117 days. Major adverse events were tolerable skin toxicities, diarrhea, and stomatitis.[Conclusion] Erlotinib was efficacious in patients with previously treated NSCLC. Efficacy and safety were similar to previous reports.
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 Completed
Date of protocol fixation
2009 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information Advances in Lung Cancer
Vol.3 No.1(2014), 10-20.
DOI:10.4236/alc.2014.31002

Management information
Registered date
2009 Year 11 Month 09 Day
Last modified on
2014 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003328

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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