UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001780 |
|---|---|
| Receipt number | 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 16:08:55 |
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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
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002146
