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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006532
Receipt No. R000007721
Scientific Title A phase II study of Docetaxel with Bevacizumab for EGFR mutation negative previously treated non-squamous non-small cell lung cancer
Date of disclosure of the study information 2011/10/14
Last modified on 2019/04/25

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Basic information
Public title A phase II study of Docetaxel with Bevacizumab for EGFR mutation negative previously treated non-squamous non-small cell lung cancer
Acronym A phase II study of Docetaxel with Bevacizumab for EGFR mutation negative previously treated non-squamous non-small cell lung cancer
Scientific Title A phase II study of Docetaxel with Bevacizumab for EGFR mutation negative previously treated non-squamous non-small cell lung cancer
Scientific Title:Acronym A phase II study of Docetaxel with Bevacizumab for EGFR mutation negative previously treated non-squamous non-small cell lung cancer
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 Investigation of the efficacy and safety of Docetaxel with Bevacizumab for EGFR mutation negative previously treated non-squamous non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression Free Survival
Key secondary outcomes Response Rate
Disease Control Rate
Overall Survival
Maximum tumor volume change
Safety Profile

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 Docetaxel with Bevacizumab
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 confirmed non-squamous non-small cell lung cancer
2. Clinical stage : IIIB/IV
3. 20<= years <70
4. Performance status (ECOG) : 0-2
5. Relapsed or progressed to one or more prior chemotherapy
6. Less than 4 weeks observation since relapse or progression.
7. No prior treatment with Docetaxel.
8. With one or more measurable disease based on RECIST
9. Adequate function of vital organs as following:
Neutrophils >= 1,500/mm3
Hemoglobin >= 9.0 g/dL
Platelets >= 75,000/mm3
AST and ALT <= 2.5ULN
Total bilirubin <= 1.5ULN
Serum albumin <= 2.5mg/dL
Serum creatinine <= 1.2mg/dL
Creatinine Clearance >= 45ml/min
Urinary protein <= 1+
10. No chemotherapy within 21days prior to the study.
No thoracic radiotherapy within 28days prior to the study.
No radiotherapy (except thoracic) within 7days prior to the study.
No G-CSF within 7days prior to study.
No pleurodesis, pleural drainage etc. within 14days prior to the study
11. A life expectancy of more than 3 months
12. Written informed consent before initiation of study-related procedures
Key exclusion criteria 1. EGFR mutation status positive
2. CNS metastasis
3. History or complication of hemoptysis with 2.5mL per time or more. Continuouis bloody phlegm more than 1 week. History or complication of bloody phlegm treated with continuous oral hemostatic agent. History or complication of bloody phlegm treated with infusional hemostatic agent.
4. Tendency to hemorrhages
5. continuous medication with anticoagulant drug(including Aspirin over 325mg/day) for Thrombus treatment
6. Invasion to major vessel or cavitations of tumor
7. Planning of concurrent thoracic radiotherapy (excluding if radiation field does not cover the chest
8. Pericardial effusion requiring drainage
9. Superior vena cava syndrome
10. Uncontrollable peptic ulcer
11. History of GI perforation
12. Uncontrollable hypertension
13. Symptomatic congestive heart failure, Unstable angina, arrhythmia requiring treatment
14. Severe myelosuppression
15. Severe infection
16. Severe psychological illness
17. Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
18. With a history of drug sensitivity for Docetaxcel or Bevacizumab.
19. In pregnancy, during breast feeding, or possibility of pregnancy.
20. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Shimizu
Organization Nihon University School of Medicine
Division name Respiratory Medicine
Zip code 173-8610
Address 30-1 Ohyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Email shimizu.tetsuo@nihon-u.ac.jp

Public contact
Name of contact person
1st name Tetsuo
Middle name
Last name Shimizu
Organization Nihon University School of Medicine
Division name Respiratory Medicine
Zip code 173-8610
Address 30-1 Ohyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Homepage URL
Email shimizu.tetsuo@nihon-u.ac.jp

Sponsor
Institute Nihon University School of Medicine
Institute
Department

Funding Source
Organization Nihon University
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 Nihon University School of Medicine
Address 30-1 Ohyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
Tel 03-3972-8111
Email hirukawa.yasuko@nihon-u.ac.jp

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 日本大学医学部附属板橋病院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2011 Year 05 Month 27 Day
Date of IRB
2011 Year 05 Month 27 Day
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
2014 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 13 Day
Last modified on
2019 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007721

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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