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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003421
Receipt No. R000004101
Scientific Title Phase I study of combination chemotherapy with erlotinib and S-1 as the 2nd or 3rd-line treatment in platinum-refractory advanced non-small cell lung cancer (TORG0808)
Date of disclosure of the study information 2010/03/31
Last modified on 2010/03/30

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Basic information
Public title Phase I study of combination chemotherapy with erlotinib and S-1 as the 2nd or 3rd-line treatment in platinum-refractory advanced non-small cell lung cancer (TORG0808)
Acronym Phase I study of combination chemotherapy with erlotinib and S-1 in pretreated non-small cell lung cancer(TORG0808)
Scientific Title Phase I study of combination chemotherapy with erlotinib and S-1 as the 2nd or 3rd-line treatment in platinum-refractory advanced non-small cell lung cancer (TORG0808)
Scientific Title:Acronym Phase I study of combination chemotherapy with erlotinib and S-1 in pretreated non-small cell lung cancer(TORG0808)
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the dose-limiting toxicity (DLT) and the maximum tolerable dose (MTD) for the following phase II study of a two-drug combination of erlotinib and S-1.
To evaluate the antitumor activity and safety of this combination.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Maximum Tolerated Dose of Erlotinib/S-1 combination therapy
Key secondary outcomes Anti tumor efficacy

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 administers 150mg/body orally once a day.
Patients receive oral doses of S-1
twice daily after meals from days 1 to 14 of each 21-day cycle at the following dose level.
Level 0:60mg/m2day
Level 1:70mg/m2day
Level 2:80mg/m2day
Initially three patients are enrolled to level 1. When DLT was observed at one of them, Additionally three patients are enrolled. If DLT is observed at one of the six, S-1 dose is escalated to level 2. In case DLT is observed at three of the three or two of the six or more, We determine level 1 as MTD.
RD is one level below MTD.
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)Histology/cytology-proven non-small cell lung cancer
2)Stage IIIB (wide radiation field, malignant pleural effusion or contralateral supraclavicular lymph node) or Stage IV
3)Previous 1- or 2-regimen chemotherapy consisting of platinum
4) No prior chemotherapy with EGFR-TKI or fluoropyrimidine
5)Presence of measurable disease
6)more than 4weeks after the last treatment
7)measurable disease per RECIST criteria
8)ECOG PS of 0-1
9)Age of 20 years or over
10)Adequate reserves for marrow, renal, hepatic, and pulmonary functions
11)Acquisition of written informed consent
Key exclusion criteria 1) no other evaluable lesion after the prior irradiation for the primary tumor
2) the superior vena caval syndrome
3) previous drug allergy
4,5) massive pericardial, pleural effusion, or ascites
6,9,14) serious underlying diseases
(interstitial pneumonia, serious cardiac diseases, serious infection)
7,8)diarrhea to last, ileus, or intestinal tract paralysis
10) previous radiotherapy for cest or ilium bone
11) symptomatic brain metastasis
12) concomitant malignancy
13) uncontrolled diabetes mellitus
15)mental disorder to become the clinical problem
16)hoped to be pregnant/ nursing
17)those judged to be not suitable by the attending physician
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsu Shinkai
Organization National hospital organization shikoku cancer center
Division name department of respiratory disease
Zip code
Address 160,Minamiumemoto-machi-ko,matsuyama,Ehime
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoyuki Nogami
Organization National hospital organization shikoku cancer center
Division name Administration office
Zip code
Address 160,Minamiumemoto-machi-ko,matsuyama,Ehime
TEL 089-999-1111
Homepage URL http://www.torg.or.jp/
Email Nnogami@shikoku-cc.go.jp

Sponsor
Institute Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization Thoracic Oncology Research Group
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization japan

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
2010 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2008 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2010 Year 04 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
2010 Year 03 Month 31 Day
Last modified on
2010 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004101

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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