UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004731 |
|---|---|
| Receipt number | R000005632 |
| Scientific Title | Phase II study of carboplatin and pemetrexed plus bevacizumab after failure of first-line EGFR TKI therapy for non-small-cell lung cancer harboring EGFR mutation. |
| Date of disclosure of the study information | 2010/12/15 |
| Last modified on | 2018/12/21 10:21:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II study of carboplatin and pemetrexed plus bevacizumab after failure of first-line EGFR TKI therapy for non-small-cell lung cancer harboring EGFR mutation.
Acronym
Phase II study of carboplatin and pemetrexed plus bevacizumab after failure of first-line EGFR TKI therapy for non-small-cell lung cancer harboring EGFR mutation.
Scientific Title
Phase II study of carboplatin and pemetrexed plus bevacizumab after failure of first-line EGFR TKI therapy for non-small-cell lung cancer harboring EGFR mutation.
Scientific Title:Acronym
Phase II study of carboplatin and pemetrexed plus bevacizumab after failure of first-line EGFR TKI therapy for non-small-cell lung cancer harboring EGFR mutation.
Region
| Japan |
Condition
Condition
Non-squamous Non-small-cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of carboplatin and pemetrexed plus bevacizumab after failure of first-line EGFR TKI therapy for non-small-cell lung cancer harboring EGFR mutation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression free survival
Overall survival
Disease control rate
1 year survival rate
Adverse events
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
Carboplatin AUC=5 day 1+
Pemetrexed 500mg/m2 day 1+
Bevacizumab 15 mg/kg day 1
q3w 4 cycles
followed by Pemetrexed 500mg/m2 day 1 + Bevacizumab 15 mg/kg day 1 q3w until disease progression
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically proven non-squamous non-small cell lung cancer
2) Non-squamous non-small-cell lung cancer harboring EGFR mutation
3) Stage IIIB, stage IV (UICC-7) or recurrent disease after surgery
4) Failure after the first-line EGFR TKI therapy
5) With measurable lesion (RECIST version 1.1)
6) Without previous radiotherapy to the primary tumor
7) Age: 20-74 years old
8) ECOG performance status of 0 or 1
9) Adequate organ function
10) Life expectancy more than 3 months
11) Written informed consent
Key exclusion criteria
1) Symptomatic brain metastasis
2) Hemoptysis (>=2.5ml)
3) Tumor invasion to the large blood vessel
4) Uncontrolled hypertension
5) Active infection
6) Severe underlying disease such as uncontrolled heart disease or diabetes mellitus
7) Receiving anticoagulants
8) Other concurrent active malignancy
9) Superior vena cava syndrome
10) Massive pleural or pericardial effusion, or ascites
11) Vertebral metastases requiring radiation therapy
12) Severe drug allergy
13) Active GI bleeding or inflammation in the abdominal cavity
14) Major surgery within 4 weeks
15) Pregnant or breast-feeding woman
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Saito |
Organization
Aichi Cancer Center Aichi Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, Japan
TEL
0564-21-6251
hsaito@acc-aichi.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Takahashi |
Organization
Aichi Cancer Center Aichi Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, JAPAN
TEL
0564-21-6251
Homepage URL
ktakahashi@acc-aichi.com
Sponsor or person
Institute
Central Japan Lung Study 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
| 2010 | Year | 12 | Month | 15 | 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
Main results already published
Date of protocol fixation
| 2010 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 15 | Day |
Last modified on
| 2018 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005632
