UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000007721