UMIN-CTR Clinical Trial

Public title

Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia

Acronym

Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia

Scientific Title

Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia

Scientific Title:Acronym

Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia

Region

Japan

Condition

advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the safety and efficacy of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small cell lung cancer with idiopathic interstitial pneumonia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

response rate

Key secondary outcomes

OS: overall survival
PFS: progression free survival
TTF: time to treatment failure
toxicity

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

carboplatin AUC = 5, day1
paclitaxel 70mg/m2, day1 ,8 ,15
bevacizumab 15mg/kg, day1
every 4 weeks, 4-6 cycle

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) non-squamous, non-small cell lung cancer
2) Age over twenty
3) Idiopathic interstitial pneumonia
4) Measurable lesion
5) expected treatment date to be 4 weeks over surgury, 2 weeks over drainage of pleural effusion, 2 weeks over biopsy requiring incision, 1 week over bronchoscopic procedure or implantation of central venous port
6) ECOG performance status 0 or 1
7) Adequate organ function
WBC>=3000/mm3 and neutrophil count >=2000/mm3
Hgb>=10.0 g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<100 IU/L, ALT=<100 IU/L, CRN=<1.5mg/dL, urine protein<= 1+
8) PaO2>=60.0 torr or SpO2>=92.0 %( room air)
9) Life expectancy > 3 months
10) Written informed consent

Key exclusion criteria

1) Secondary interstitial pneumonia.
2) History of acute exacerbation of interstitial pneumonia within 3 months.
3) Subacute progression of interstitial pneumonia within 3 months.
4) Using prednisolone or immune-suppressive agent.
5) In need of home oxygen therapy.
6) Past history of severe drug allergy.
7) Active infectious disease.
8) Severe complications
9) brain metastasis.
10) Uncontrollable effusion.
11) history of hemosputum
12) tumor invasion into thoracic large vessels or tumor with cavity
13)active gastrointestinal ulcer
14)bleeding tendency
15)operation wound not cured
16)thrombosis in need with treatment
17) Active combined malignancy
18) Any ineligible case judged by physician.

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Nobuyuki Katakami

Organization

Kobe City Medical Center General Hospital

Division name

Department of Medical Oncology

Zip code

Address

2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan 650-0047

TEL

078-302-4321

Email

nkatakami@kcho.jp

Name of contact person

1st name
Middle name
Last name	Kojiro Otsuka

Organization

Kobe City Medical Center General Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan 650-0047

TEL

078-302-4321

Homepage URL

Email

kotsuka@kcho.jp

Institute

IP lung cancer study group

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

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

07

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

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

Open public recruiting

Date of protocol fixation

2012

Year

11

Month

21

Day

Date of IRB

Anticipated trial start date

2012

Year

12

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

07

Month

15

Day

Last modified on

2018

Year

01

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021197