UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003421 |
|---|---|
| Receipt number | 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 | 2020/11/12 10:41:15 |
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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
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/
Nnogami@shikoku-cc.go.jp
Sponsor or person
Institute
Thoracic Oncology Research Group
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10637-020-00985-4
Number of participants that the trial has enrolled
7
Results
A total of 7 patients with performance-status (PS) 0 or 1 were enrolled as subjects in phase I. Five of these subjects were EGFR-mutation positive. Four subjects were enrolled at S-1 dose level 1 and 3 were enrolled at S-1 dose level 2. No dose-limiting toxicities were observed in these subjects. The RD was decided as erlotinib 150 mg/body and S-1 80 mg/m2. In phase I, 5 subjects achieved partial response, and the ORR was 71.4%.
Results date posted
| 2020 | Year | 11 | Month | 12 | Day |
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
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004101
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