UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002900 |
|---|---|
| Receipt number | R000003538 |
| Scientific Title | A Phase I/II study of Pemetrexed plus Erlotinib therapy in Previously Treated Non-Small-Cell Lung Cancer. |
| Date of disclosure of the study information | 2009/12/15 |
| Last modified on | 2012/12/15 22:03:23 |
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Basic information
Public title
A Phase I/II study of Pemetrexed plus Erlotinib therapy in Previously Treated Non-Small-Cell Lung Cancer.
Acronym
A Phase I/II study of Pemetrexed plus Erlotinib therapy in Previously Treated Non-Small-Cell Lung Cancer.
Scientific Title
A Phase I/II study of Pemetrexed plus Erlotinib therapy in Previously Treated Non-Small-Cell Lung Cancer.
Scientific Title:Acronym
A Phase I/II study of Pemetrexed plus Erlotinib therapy in Previously Treated Non-Small-Cell Lung Cancer.
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the recommend dose of pemetrexed plus erlotinib therapy, and to investigeate the efficacy and safety of the recommend dose for previously treated non-small-cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Response 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 and Pemetrexed combinationtherapy
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)Stage IIIB/IV non-small cell lung cancer proven by histology and/or cytology
2)Non-Sqamous cell carcinoma
3)Patients who have previously treated with one chemotherapy.
4)Patients aged 20 years or older.
5)No prior treatment with TKI or Mab which affect to HER family.
6)No prior treatment with pemetrexed.
7)Patients who has at least one or more measurable lesion(s) by RECIST.
8)Performance status (ECOG) 0-2
9)Patients who can be hospitalized for at least one to two weeks after beginning of the treatment or under similar management.
10) Adequate organ functions, evaluated within 2 weeks before enrollment, as;
a) WBC >= 3,000/mm3
b) Netrophile >= 1,500/mm3
c) Plt >= 100,000/mm3
d) Hb >= 9.0 g/dL
e) AST/ALT, x 2 of upper limit of normal or less.
f) T. Bil <= 1.5 g/dL
g) Serum creatinine, x 1.5 of upper limit of normal or less.
h) SpO2 >= 90% as room air
11)Patients are excepted to live over 3 months.
12)Interval from previous treatment, of following, at enrollment;
(1)Equal or more than 3 weeks after completion of previous chemotherapy
(2)Equal or more than 4 weeks after completion of thoracic irradiation. / Equal or more than 1 week after completion of irradiation except for thoracic irradiation
(3)Equal or more than 2 weeks after surgical intervention.
Key exclusion criteria
1) Patients with idiopathic pulmonary fibrosis, other interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug induced pulmonary damage
2) Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage
3) Patients with infection requiring iv administration of antibiotics and/or antifungal agents
4) Patients unable to be treated with PO drugs
5) Clinically significant eye diseases such as severe dry eye, keratoconjunctivitis
6) Pregnancy, breast feeding and suspected pregnancy
7) Severe bone marrow suppression
8) Symptomatic brain metastasis
9) Active synchronous malignancies
10) Severe renal function disorder (creatinin clearlance less than 45mL/min)
11) Uncontrolled diabetes mellitus
12) Other clinically significant complications
13) Other conditions inadequate for this research
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Tachibana |
Organization
Osaka Univ.Hospital
Division name
Respiratory Medicine
Zip code
Address
2-15 Yamada-oka, Suita, Osaka 565-0871, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kijima |
Organization
Osaka Univ.Hospital
Division name
Respiratory Medicine
Zip code
Address
2-15 Yamada-oka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3833
Homepage URL
tkijima@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka Univ.Hospital Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka Univ.Hospital Respiratory Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Police Hospital
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 15 | 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
Completed
Date of protocol fixation
| 2009 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 15 | Day |
Last modified on
| 2012 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003538
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