UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007397 |
|---|---|
| Receipt number | 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 14:12:27 |
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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
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
im62@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University, School of Medicine, Department of Hematology and Resporatory Medicine
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008459
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