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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013224
Receipt No. R000015433
Scientific Title 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
Date of disclosure of the study information 2014/02/22
Last modified on 2017/12/31

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Basic information
Public title 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
Acronym 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
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Akihito Yokoyama
Organization Kochi University, School of Medicine
Division name Dept of Hematology and Respiratory Medicine
Zip code
Address Kohasu, Okocho, Nankoku city, Kochi
TEL 088-880-2345
Email im25@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Kubota
Organization Kochi University, School of Medicine
Division name Dept of Hematology and Respiratory Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://ar.iiarjournals.org/content/36/1/307.long
Number of participants that the trial has enrolled
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.
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
2013 Year 12 Month 26 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000015433

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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