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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007397
Receipt No. R000008459
Scientific Title A phase II study of Erlotinib plus Pemetrexed for previously treated Non Small Cell Lung Cancer
Date of disclosure of the study information 2012/03/01
Last modified on 2014/04/01

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Basic information
Public title A phase II study of Erlotinib plus Pemetrexed for previously treated Non Small Cell Lung Cancer
Acronym A phase II study of Erlotinib plus Pemetrexed for previously treated NSCLC
Scientific Title A phase II study of Erlotinib plus Pemetrexed for previously treated Non Small Cell Lung Cancer
Scientific Title:Acronym A phase II study of Erlotinib plus Pemetrexed for previously treated NSCLC
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 plus Pemetrexed 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 a combined chemotherapy of Erlotinib plus Pemetrexed
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 confirmed non-squamuous*, non-small cell lung cancer (NSCLC).
*Cases with histological diagnosis of non-small cell lung cancer only, and /or cases with non-small cell lung cancer with less than 50% of squamous components will be applicable.
2) Stage IIIB/IV (UICC-7) or postoperative recurrence NSCLC
3) Patients who have previously treated with one or two chemotherapy regimen(s). Postoperative oral UFT therapy does not mean previous chemotherapy regimen.
4) Patients who have never received either epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) (EGFR-TKI) or pemetrexed.
5) Patients whose EGFR gene mutation in tumor cells is negative or unknown.
6) Patients who has at least one or more measurable lesion(s) by RECIST.
7) Performance status (ECOG) 0-2
8) Patients who can be hospitalized for at least two weeks after beginning of the treatment or under similar management.
9) Patients aged 20 years or older.
10) Sufficient function of main organ and bone marrow filling the following criteria:
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.
11) Patients who are considered to survive for more than 3 months.
12) 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)
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 who have previously treated with EGFR-TKI and / or pemetrexed
3) Patients with active severe infections
4) Impossible cases with oral administration
5) Patients with active opthalmological disease
6) Pregnancy or lactation
7) Patients with symptomatic brain metastasis
8) Patients with active concomitant malignancy
9) Patients with uncontrollable complications
(e.g. uncontrollable heart disease, severe arrhythmia, continuous diarrhea)
10) Inappropriate patients for this study judged by the physicians
Target sample size 27

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
TEL 088-880-2345
Email im62@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
TEL 088-880-2345
Homepage URL
Email im62@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)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 01 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 Terminated
Date of protocol fixation
2012 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2014 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 02 Month 28 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=R000008459

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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