UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of carboplatin, paclitaxel and bevacizumab in advanced non-squamous non-small-cell lung cancer with idiopathic interstitial pneumonias
Title of the study (Brief title)	Feasibility study of carboplatin, paclitaxel and bevacizumab in advanced non-squamous non-small-cell lung cancer with idiopathic interstitial pneumonias
Region	Japan

Condition
Condition	Advanced non-squamous non-small-cell lung cancer with idiopathic interstitial pneumonias
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and efficacy of carboplatin, paclitaxel and bevacizumab in patients with advanced non-squamous non-small-cell lung cancer with idiopathic interstitial pneumonias
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety (frequency of acute exacerbation of interstitial pneumonias)
Key secondary outcomes	progression-free survival, overall survival, response rate, time to response, frequency of of acute exacerbation of interstitial pneumonias by CTCAE v4.03 grades

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	chemotherapy(carboplatin, paclitaxel and 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	74 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Pathologically confirmed non-squamous non-small-cell lung cancer 2.Clinical stage IIIB, IV or post-operative recurrence 3.Chemotherapy naive patients (permit using picibanil for pleurodesis) 4.Stable idiopathic interstitial pneumonia confirmed by high resolution chest CT(taking predonine less than 0.25mg/kg/day or 10mg/day can be allowed) 5.ECOG Performance status 0-1 6.Age over 20 -74 years. 7.Adequate organ function 8.Radiation therapy within 14 days prior to enrollment, major surgery within 28 days prior to enrollment, minor surgery within 7 days prior to enrollment, blood transfusion or administration of hematopoietic factor within 14 days prior to enrollment. 9. Life expectancy > 3 months 10. Signed informed consent
Key exclusion criteria	1.Acute or subacute idiopathic interstitial pneumonia 2.Being suspected or experienced acute exacerbation of idiopathic interstitial pneumonia. 3.Receiving immunosuppressants except for predonine 4.Having collagen diseases 5.Having central nervous system (CNS) metastases 6.History of gross hemoptysis (2.5ml or more) or severe hemosputum (reciving hemostatic drug) 7.Evidence of tumor invading large vessel, trachea or main bronchus on imaging 8.Patients who have received a radiation therapy in chest 9.Having an uncontrolled infection 10.Having a fever (more than 38 degrees (Celsius)) 11.Having severe complications 12.Having massive ascites, pleural effusion or pericardial effusion 13.Active concomitant malignancy without evidence of recurrence within 5 years 14.Having severe drug allegy 15.Evidence of gastrointestinal bleeding, intestinal obstruction and gastrointestinal ulceration 16.History or evidence of uncontrollable gastrointestinal ulceration or gastrointestinal perforation (within 1 year) 17.Having a tendency to bleed. Receiving anticoagulant drug (except Aspirin under 324mg/day). 18.Having a schedule of operations 19.Pulmonary tumor with the cavity (more than 1cm) 20.History of pregnancy or lactation, 21.History of myocardial infarction or cerebral infarction (within 1 year) 22.Haiving hypersensitivity to carboplatin, paclitaxel and bevacizumab, Cremophor E or alchol. 23.Using a home oxygen therapy 24.Decision of ineligibility by the attending physician
Target sample size	27

Research contact person
Name of lead principal investigator	Kazuma Kishi
Organization	Toranomon Hospital
Division name	Respiratory Medicine, Respiratory Center
Address	2-2-2 Toranomon, Minato-ku, Tokyo, Japan, 105-8470
TEL
Email

Public contact
Name of contact person	Yuji Minegishi
Organization	Nippon Medical School,
Division name	Division of Pulmonary Medicine, Infectious Disease, and Oncology, Department of Internal Medicine
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan, 113-8602
TEL
Homepage URL
Email

Sponsor
Institute	The Ministry of Health, Labour and Welfare of Japan awarded to the Study Group on Diffuse Pulmonary Disorders, Scientific Research/Research on intractable diseases
Institute
Department

Funding Source
Organization	The Ministry of Health, Labour and Welfare of Japan awarded to the Study Group on Diffuse Pulmonary Disorders, Scientific Research/Research on intractable diseases
Organization
Division
Category of Funding Organization
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	2012 Year 06 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 05 Day
Anticipated trial start date	2012 Year 06 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	2012 Year 06 Month 17 Day
Last modified on	2018 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008829