UMIN-CTR Clinical Trial

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

non-squamous, non-small cell lung cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

response rate

Key secondary outcomes

progression free survival, overall survival, safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

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 (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

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

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

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

Institute

Department

Personal name

Organization

Kochi Unicersity

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

02

Month

22

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

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

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 related information

Registered date

2014

Year

02

Month

22

Day

Last modified on

2017

Year

12

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015433