UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II Study of Carboplatin plus weekly nab-Paclitaxel in combination with Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous, non-small cell lung cancer
Title of the study (Brief title)	Phase II study of CBDCA+weekly nab-PTX+Bev in chemo-naive patients with stage IIIB and IV non-sq, non-small cell lung cancer
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 + weekly nab-Paclitaxel + Bevacizumab in chemo-naive stage IIIB and IV non-squamous, non-small cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	response rate
Key secondary outcomes	progression free survival, overall survival, safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
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 (AUC 6, div), Bevacizumab (15 mg/kg, div) on day 1 and nab-paclitaxel (100 mg/m2, div) on day 1, 8, 15 every 4 weeks, threee to six cycles. Patients who achieve disease control (response or stable disease) without unacceptable toxicity receive Bevacizumab maintenance therapy (15 mg/kg, div) on day 1, every three weeks, until disease progression.
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) histologically or cytologically comfirmed non-squamous*, non-small cell lung cancer *Cases with histological diagnosis of non-small cell lung cancer only, and/or cases with non-small cell lung cancer with less than 50% of squamous components will be applicable. 2) Stage IIIB/IV (UICC-7) or postoperative recurrence NSCLC 3) chemo-naive patients *post-operative therapy with oral UFT is applicable. 4) patients aged 20 years or older 5) ECOG performance status of 0 or 1 6) Measurable by RECIST (ver 1.1) criteria. 7) Patients who has the following periods: palliative radiotherapy (thorax excluded), 2 weeks; operation, 4 weeks; chest drainage, 2 weeks; biopsy with incision, port custody, and treatment for injury, 2 weeks; aspiration biopsy cytology, 1 week 8) adequate bone marrow, liver,and renal functions: neutorophil >=1,500/mm3; platelet >=100,000/mm3; Hb >=9.0 g/dl; AST and ALT <2.5x of upper limit of normal (ULN); total bilirubin <=1.5x of upper limit of normal (ULN); serum creatinin <=1.2 mg/dL; SpO2>90; PT-INT <1.5; urinary protein <=1+or 2 g/24h 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 (pleurodesis with other than OK432 is not acceptable) 3) current nervous symptom 4) severe cardiac disease 5) current or previous histoty of hemoptysis (2.5 mL) due to NSCLC 6) history of hemoptysis (over 1 week) or receive oral/i.v. hemostatic drug 7) uncontrolled hypertension 8) Patients with active lung disease such as interstitial pneumonia,radiation pneumonitis, pulmonary infection, or drug-induced lung damage 9) current or previous (within the last 1 year) history of GI perforation 10) history of myocardial infarction and cerebral infarction 11) history of drug allergy 12) active concomitant malignancy 13) pregnant or lactating women or those who declined contraception 14) those judged to be not suitable by the attending physician
Target sample size	24

Research contact person
Name of lead principal investigator	Akihito Yokoyama
Organization	Kochi University, School of Medicine
Division name	Dept of Hematology and Respiratory Medicine
Address	Kohasu, Okocho, Nankoku city, Kochi
TEL	088-880-2345
Email	im25@kochi-u.ac.jp

Public contact
Name of contact person	Tetsuya Kubota
Organization	Kochi University, School of Medicine
Division name	Dept of Hematology and Respiratory Medicine
Address	Kohasu, Okocho, Nankoku city, Kochi
TEL	088-880-2345
Homepage URL
Email	kubotat@kochi-u.ac.jp

Sponsor
Institute	Kochi University
Institute
Department

Funding Source
Organization	Kochi Unicersity
Organization
Division
Category of Funding Organization	Other
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	2014 Year 02 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 26 Day
Anticipated trial start date	2013 Year 12 Month 26 Day
Last follow-up date	2018 Year 12 Month 31 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	http://ar.iiarjournals.org/content/36/1/307.long
Results	Anticancer Research 2016;36:307-312 AIM: The present study aimed to evaluate the effectiveness and safety of weekly paclitaxel (PTX) combined with carboplatin (CBDCA) plus bevacizumab (BEV), followed by maintenance BEV in patients with advanced NSCLC. PATIENTS AND METHODS: Patients with unresectable stage IIIB and IV NSCLC (n=43) were treated with CBDCA (AUC 6, day 1), BEV (15 mg/kg, day 1), and PTX (70 mg/m(2), days 1, 8, 15) intravenously every 4 weeks, for 3 to 6 cycles, followed by maintenance BEV (15 mg/kg) every 3 weeks. RESULTS: The objective response rate and disease control rate were 67.4% and 90.7%, respectively. The median progression-free survival was 7.6 months. The median overall survival was 17.7 months. Common adverse events were tolerable bone marrow suppression, fatigue, hypertension, and nasal bleeding. CONCLUSION: Weekly administration of PTX combined with CBDCA plus BEV therapy was effective, and well-tolerated by advanced NSCLC patients.
Other related information

Management information
Registered date	2014 Year 02 Month 22 Day
Last modified on	2017 Year 12 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015433