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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001780
Receipt No. R000002146
Scientific Title Phase I/II study of intermittent erlotinib in combination with docetaxel in patients with recurrent non-small cell lung cancer
Date of disclosure of the study information 2009/03/17
Last modified on 2019/07/17

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Basic information
Public title Phase I/II study of intermittent erlotinib in combination with docetaxel in patients with recurrent non-small cell lung cancer
Acronym Intermittent erlotinib in combination with docetaxel in patients with recurrent NSCLC
Scientific Title Phase I/II study of intermittent erlotinib in combination with docetaxel in patients with recurrent non-small cell lung cancer
Scientific Title:Acronym Intermittent erlotinib in combination with docetaxel in patients with recurrent NSCLC
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of intermittent erlotinib in combination with docetaxel in patients with recurrent NSCLC
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I study:Safety
Determine recommended dose
Phase II study: Response rate
Key secondary outcomes Safety
Disease control rate
Progression free survival
Overall survival
1 year survival rate

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 plus Docetaxel
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 Phase1
1)Histologically or cytologically Non-small cell lung cancer
2)EGFR wild type of Exon 19 and 21
3)Unsuitable for surgery nor radiation therapy
4)Stage IIIB, or IV
5)Previously treated with one chemotherapy or chemoradiotherapy regimen
6)Aged 20 years and older
7)ECOG performance status 0-1
8)Adequate organ functions
9)Life expectancy of at least 3 months
10)At least 4weeks after the ad ministration of the previous chemotherapy and/or chest RT and surgery,2weeks after RT for ex-thoracic lesion
11)Written informed consent

Phase2
1)Histologically or cytologically Non-small cell lung cancer
2)EGFR wild type of Exon 18, 19 and 21
3)Unsuitable for surgery nor radiation therapy
4)Stage IIIB, or IV
5)Previously treated with one chemotherapy or chemoradiotherapy regimen
6)Measurable lesion defined by RECIST ver1.1
7)Aged 20 years and older
8)ECOG performance status 0-1
9)Adequate organ functions
10)Life expectancy of at least 3 months
11)At least 4weeks after the ad ministration of the previous chemotherapy and/or chest RT and surgery,2weeks after RT for ex-thoracic lesion
12)Written informed consent
Key exclusion criteria Phase1
1)Previous treatment with an agent of which the main mechanism of action is inhibition of EGFR families or its associated tyrosine kinase
2)Previously received docetaxel
3)Obvious pulmonary interstitial abnormality on chest CT
4)Uncontrolled infections or uncontrolled serious systematic disease
5)symptomatic brain metastasis
6)Other co-existing malignancies or malignancies diagnosed within the last 5 years
7)significant pleural effusion, pericardial effusions or ascites,
8)patient who cannot eat enough
9)severe drug allergies
10)Hypersensitive to polysorbate80
11)Pregnant or breast feeding
12)HBs-Ag positive or HCV-Ab positive
13)Patient for whom this clinical trial is judged to be inappropriate by physicians

Phase2
1)Previous treatment with an agent of which the main mechanism of action is inhibition of EGFR families or its associated tyrosine kinase
2)Previously received docetaxel
3)Obvious pulmonary interstitial abnormality on chest CT
4)Uncontrolled significant active infections or uncontrolled systematic disease
5)symptomatic brain metastasis
6)Other co-existing malignancies or malignancies diagnosed within the last 5 years
7)significant pleural effusion, pericardial effusions or ascites,
8)patient who cannot eat enough
9)severe drug allergies
10)Hypersensitive to polysorbate80
11)Pregnant or breast feeding
12)HBs-Ag positive or HCV-Ab positive
13)Patient for whom this clinical trial is judged to be inappropriate by physicians
Target sample size 57

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinzoh Kudoh(Tatsuo Kimura)
Organization Osaka City University Medical School
Division name Department of Respiraory Medicine
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka
TEL 06-6645-3803
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
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

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/31242302
Number of participants that the trial has enrolled 60
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 02 Month 21 Day
Date of IRB
2009 Year 03 Month 26 Day
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2017 Year 04 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 03 Month 17 Day
Last modified on
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002146

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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