UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Study of Carboplatin+Pemetrexed+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous non-small cell lung cancer(NSCLC).
Title of the study (Brief title)	Phase II Study of Carboplatin+Pemetrexed+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous non-small cell lung cancer(NSCLC).
Region	Japan

Condition
Condition	non-squamous non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Carboplatin+Pemetrexed+Bevacizumab in chemo-naive stage IIIB/IV non-squamous non-small cell lung cancer(NSCLC).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	Progression Free Survival Overall Survival Time to Response Safety

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	Patients receive CBDCA(AUC6,i.v.), Pemetrexed(500mg/m2,i.v.) and Bevacizumab(15mg/kg,i.v.) on Day1, every three weeks, up to six cycles.Patients who achieved disease control(response or stable disease) without unacceptable toxicity receive Pemetrexed(500mg/m2,i.v.) and Bevacizumab(15mg/kg,i.v.) on Day1, every three weeks, untill disease porogression.
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(NSCLC) 2)Stage IIIB/IV(UICC-7) or postoperative recurrence NSCLC 3)cheno-naive patient(except oral 5-FU) 4)Age:20 years to less than 75 years. 5)ECOG performance status of 0 or 1 6)Measurable by RECST(ver 1.1) criteria. 7)Patient who has the following periods. palliative radiotherapy(ex thorax):2 weeks operation:4 weeks chest drainage:2 weeks Biopsy with incision, port custody, and treatment to injury:2 weeks Aspiration biopsy cytology:1 week 8)adequate bone marrow, liver, and renal functions neutro > 1,500/mm-3 Plt > 100,000/mm-3 Hb > 9.0 g/dL-1 neutro > 2,000 mm-3 AST(GOT), ALT(GPT)< 2.5x upper normal limit T-Bil< 1.5x upper normal limit creatinine clearance > 45 ml/min SpO2> 93% Urinari protein <= 1+ or 2g/24hrs 9)a life expectancy of 3 months or more 10)Written informed consent
Key exclusion criteria	1)Uncontrolled infection or Serious medical complications 2)massive pleural effusion or ascites. (accept controrable pleural effusion with OK-432) 3)current or previous treated brain metastasis 4)severe cardiac disease 5)uncontrolled diabetes mellitus 6)receiving anticoagulant drug(except Aspirin under 325mg/day) 7)current or previous history of hemoptysis(>=2.5ML) due to NSCLC 8)history of hemoptysis(over 1 week) or receive oral/i.v. hemostatic drug 9)uncontrolled hyper tension 10)current or previous (within the last 1 year) history of GI perforation 11)interstitial pneumonia or lung fibrosis evident on CT 12)history of drug induced interstitial pneumonia 13)Patient who has been scheduling operation for examination period 14)treatment history of carboplatin, pemetrexed and bevacizumab 15)severe drug allergy 16)Patient who cannot or doesn't hope administer multivitamin and vitamin B12 17)active concomitant malignancy 18)severe psychological disease 19)pregnant or lactating women or those who declined contraception 20)those judged to be not suitable by the attending physician
Target sample size	25

Research contact person
Name of lead principal investigator	TAKASHI YOKOI
Organization	Kansai Medical University Hirakata Hospital
Division name	respiratory medicine
Address	2-3-1, Shinmachi, Hirakata-city, OSAKA
TEL	072-804-0101
Email	yokoit@hirakata.kmu.ac.jp

Public contact
Name of contact person	Takashi Yokoi
Organization	Kansai Medical University Hirakata Hospital
Division name	respiratory medicine
Address	2-3-1 Shinmachi,Hirakata,Osaka,Japan
TEL	072-804-0101
Homepage URL
Email	yokoit@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Hirakata Hospital
Institute
Department

Funding Source
Organization	Kansai Medical University Hirakata Hospital
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	関西医科大学附属枚方病院（大阪府）

Other administrative information
Date of disclosure of the study information	2010 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 03 Month 24 Day
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date	2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2010 Year 03 Month 27 Day
Last modified on	2017 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004112