UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia
Title of the study (Brief title)	Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia
Region	Japan

Condition
Condition	advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety and efficacy of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small cell lung cancer with idiopathic interstitial pneumonia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	response rate
Key secondary outcomes	OS: overall survival PFS: progression free survival TTF: time to treatment failure toxicity

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, day1 paclitaxel 70mg/m2, day1 ,8 ,15 bevacizumab 15mg/kg, day1 every 4 weeks, 4-6 cycle
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) non-squamous, non-small cell lung cancer 2) Age over twenty 3) Idiopathic interstitial pneumonia 4) Measurable lesion 5) expected treatment date to be 4 weeks over surgury, 2 weeks over drainage of pleural effusion, 2 weeks over biopsy requiring incision, 1 week over bronchoscopic procedure or implantation of central venous port 6) ECOG performance status 0 or 1 7) Adequate organ function WBC>=3000/mm3 and neutrophil count >=2000/mm3 Hgb>=10.0 g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<100 IU/L, ALT=<100 IU/L, CRN=<1.5mg/dL, urine protein<= 1+ 8) PaO2>=60.0 torr or SpO2>=92.0 %( room air) 9) Life expectancy > 3 months 10) Written informed consent
Key exclusion criteria	1) Secondary interstitial pneumonia. 2) History of acute exacerbation of interstitial pneumonia within 3 months. 3) Subacute progression of interstitial pneumonia within 3 months. 4) Using prednisolone or immune-suppressive agent. 5) In need of home oxygen therapy. 6) Past history of severe drug allergy. 7) Active infectious disease. 8) Severe complications 9) brain metastasis. 10) Uncontrollable effusion. 11) history of hemosputum 12) tumor invasion into thoracic large vessels or tumor with cavity 13)active gastrointestinal ulcer 14)bleeding tendency 15)operation wound not cured 16)thrombosis in need with treatment 17) Active combined malignancy 18) Any ineligible case judged by physician.
Target sample size	35

Research contact person
Name of lead principal investigator	Nobuyuki Katakami
Organization	Kobe City Medical Center General Hospital
Division name	Department of Medical Oncology
Address	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan 650-0047
TEL	078-302-4321
Email	nkatakami@kcho.jp

Public contact
Name of contact person	Kojiro Otsuka
Organization	Kobe City Medical Center General Hospital
Division name	Department of Respiratory Medicine
Address	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan 650-0047
TEL	078-302-4321
Homepage URL
Email	kotsuka@kcho.jp

Sponsor
Institute	IP lung cancer study group
Institute
Department

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)

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	2015 Year 07 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 11 Month 21 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 15 Day
Last modified on	2018 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021197