UMIN-CTR Clinical Trial

Public title

Phase II study of continuation maintenance by use of nab-Paclitaxel and Bevacizumab after induction chemotherapy of Carboplatin and nab-Paclitaxel pulse bevacizumab in chemotherapy-naïve patients with Stage IIIB / IV non-squamous and non-small cell lung cancer.

Acronym

Phase II of Carboplatin (CBDCA) and nab-Paclitaxel (nab-PTX) pulse bevacizumab (BEV) followed by nab-Paclitaxel and bevacizumab

Scientific Title

Phase II study of continuation maintenance by use of nab-Paclitaxel and Bevacizumab after induction chemotherapy of Carboplatin and nab-Paclitaxel pulse bevacizumab in chemotherapy-naïve patients with Stage IIIB / IV non-squamous and non-small cell lung cancer.

Scientific Title:Acronym

Phase II of Carboplatin (CBDCA) and nab-Paclitaxel (nab-PTX) pulse bevacizumab (BEV) followed by nab-Paclitaxel and bevacizumab

Region

Japan

Condition

Non-small and non-squamous cell lung cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of nab-PTX and BEV after induction by CBDCA and nab-PTX pulse BEV in chemotherapy-naïve patients with Stage IIIB / IV non-squamous and non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

Progression free survival (PFS) from the beginning of maintenance therapy

Key secondary outcomes

Response rate (RR) by RECIST, Disease control rate (DCR), Overall survival (OS), Time to treatment failure (TTF), maintenance rate, PFS from the start of induction therapy, Adverse events,

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

CBDCA and nab-PTX pulse BEV followed by nab-PTX pulse BEV

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

I) Eligibility criteria for 1st registration
1) Histologically or cytologically proven non-squamous and non-small cell lung cancer
2) Stage IIIB/IV without indication for radical thoracic irradiation or recurrence after surgical treatment
3) Naive treatment of cytotoxic chemotherapy and recurrence more than 6 months ago after completion of postoperable adjuvant chemotherapy. OK432 pleurodesis for malignant pleural effusion is acceptable for pretreatment.
4)Eastern Cooperative Oncology Group performance status of 0-1
5)Age > or = 20 years
6) Tumor has the evaluable lesion.
7) Adequate organ function, Adequate organ function within 2 weeks
a) Leukocyte count > or = 3,000/mm3
b) Neutrophil count > or = 1,500/mm3
c) Platelet count > or = 100,000/mm3
d) Hemoglobin concentration > or = 9.0 g/dl
e) Total bilirubin level < or = 1.5 mg/dl
f) Aspartate aminotransferase and alanine aminotransferase levels < or = 100 IU/L
g) Serum creatinine levels < or = 1.5 mg/dl
h) Acceptable cardiac function
i) Peripheral neuropathy < or = grade 1
9) Estimating Survival more than 3 months
10)Written informed consent

II) Eligibility Criteria for 2nd registration
1) More than 2 cycles of induction chemotherapy
2) Response criteria of induction chemotherapy achieved more than and equal to SD.
3) Recover within 6 weeks after start of last cycle of induction therapy.
1.PS 0-1
2.Leukocyte count > or = 3,000/mm3
3.Neutrophil count > or = 1,500/mm3
4.Platelet count > or = 100,000/mm3
5.Hemoglobin concentration > or = 8.0 g/dl
6.Total bilirubin level < or = 1.5 mg/dl
7.Aspartate aminotransferase and alanine aminotransferase levels < or = 100 IU/L
8.Serum creatinine levels < or = 1.5 mg/dl
9.Peripheral neuropathy < or = grade 2
10.Hypertension < or = grade 2
11.proteinuria < or = grade 2
12.any bleeding < or = grade 1
13.thromboembolic event absence

Key exclusion criteria

1) Patients with squamous cell lung cancer.
2) History of allergic reaction for agents of present treatment
3) Severe myelosupperssion, renal dysfunction or hepatic dysfunction
4) Active concomitant malignancy except carcinoma in situ, intra-mucosal carcinoma or cancer with more than 5 year disease free
5) Active infection more than and equal to grade 2
6) Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage
7) Patients required for continuing more than and equal to 10 mg/day of steroid therapy
8) A history of significant hemoptysis (> 2.5 mL red blood per episode) within 3 months before enrolment
9) History of thromboembolic events
10) Any history of cerebral, myocardial, and pulmonary infarction
11) Bleeding tendency, blood coagulation disorder
12) Other ineligible for bevacizumab
13) Pregnant status or lactation
14) Uncontrolled psychiatric disease
15) Other ineligible status judged by medical oncologist.

Target sample size

42

Name of lead principal investigator

1st name
Middle name
Last name	Yuichiro Takeda

Organization

National Center for Global health and Medicine-Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan

TEL

03-3202-7181

Email

ytakeda@hosp.ncgm.go.jp

Name of contact person

1st name
Middle name
Last name	Yuichiro Takeda

Organization

National Center for Global health and Medicine-Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan

TEL

03-3202-7181

Homepage URL

Email

ytakeda@hosp.ncgm.go.jp

Institute

Department of Respiratory Medicine
National Center for Global health and Medicine-Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None

Co-sponsor

None

Name of secondary funder(s)

None

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

慶応義塾大学病院　呼吸器内科　(東京都）
災害医療センター　呼吸器内科　(東京都）
帝京大学医学部附属病院　呼吸器・アレルギー内科　(東京都）
東京医科大学病院　呼吸器・甲状腺外科　(東京都）
東京女子医科大学病院　呼吸器内科　(東京都）
虎の門病院　呼吸器センター内科　(東京都）　
国立国際医療研究センター　呼吸器内科　(東京都）

Date of disclosure of the study information

2013

Year

12

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Because of slow accrual, this study will not be capable of completion. The study committee decided termination of this study.

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

Terminated

Date of protocol fixation

2013

Year

09

Month

12

Day

Date of IRB

Anticipated trial start date

2013

Year

12

Month

02

Day

Last follow-up date

2018

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

12

Month

01

Day

Last modified on

2018

Year

06

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014551