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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002900
Receipt No. 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

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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
Email

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
Email tkijima@imed3.med.osaka-u.ac.jp

Sponsor
Institute Osaka Univ.Hospital Respiratory Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003538

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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