UMIN-CTR Clinical Trial

Public title

A Phase II Study of Carboplatin+weekly Paclitaxel+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous, non-small cell lung cancer.

Acronym

Phase II study of CBDCA+weekly 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+weekly Paclitaxel+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 PTX+Bev in chemo-naive patients with stage IIIB and IV non-sq, non-small cell lung cancer.

Region

Japan

Condition

non-squamous, non-small cell lung cancer

Classification by specialty

Medicine in general

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of Carboplatin + weekly Paclitaxel + Bevacizumab in chemo-naive stageIIIB and IV non-squamous, non-small cell lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

response rate

Key secondary outcomes

progression free survival, overall survival, time to progression, safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients receive CBDCA(AUC 6,div), Bevacizumab (15mg/kg,div) on day 1 and paclitaxel (70mg/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(15mg/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

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 to injury, 2weeks;
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;
urinari protein <=1+or 2g/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(accept controrable pleural effusion with OK-432)
3)current nervous symptom
4)severe cardiac disease
5)current or previous histoty of hemoptysis(2.5ml)due to NSCLC
6)history of hemoptysis(over 1week) or receive oral/i.v. hemostatic drug
7)uncontrolled hypertension
8)Patients with active lung disease such as interstitial pneumonia,radiation pneumonitis,plumonary 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

43

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

im62@kochi-u.ac.jp

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

Institute

Kochi University, School of Medicine, Department of Hematology and Respiratory Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

22-9

Org. issuing International ID_1

Kochi University

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

高知大学医学部附属病院（高知県）、高知医療センター（高知県）、国立病院機構高知病院（高知県）、近森病院（高知県）

Date of disclosure of the study information

2010

Year

05

Month

30

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://ar.iiarjournals.org/content/36/1/307.long

Number of participants that the trial has enrolled

Results

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/m2, 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

Recruitment status

Completed

Date of protocol fixation

2010

Year

03

Month

24

Day

Date of IRB

Anticipated trial start date

2010

Year

06

Month

01

Day

Last follow-up date

2014

Year

11

Month

01

Day

Date of closure to data entry

2014

Year

12

Month

31

Day

Date trial data considered complete

2014

Year

12

Month

31

Day

Date analysis concluded

2015

Year

03

Month

31

Day

Other related information

Registered date

2010

Year

05

Month

30

Day

Last modified on

2016

Year

01

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004456