UMIN-CTR Clinical Trial

Public title

A Phase II Trial of Abraxane in Patients with Advanced Non-Small Cell Lung Cancer

Acronym

A Phase II Trial of Abraxane in Patients with Advanced Non-Small Cell Lung Cancer

Scientific Title

A Phase II Trial of Abraxane in Patients with Advanced Non-Small Cell Lung Cancer

Scientific Title:Acronym

A Phase II Trial of Abraxane in Patients with Advanced Non-Small Cell Lung Cancer

Region

Japan

Condition

Non-small cell carcinoma

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate for efficacy and toxicities of Abraxane monotherapy for previously treated advanced 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, 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

Abraxane (100mg/m2) is administered by an infusion lasting 30 minutes on days 1, 8, 15 every 4 weeks.

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 confirmed advanced non-small-cell lung cancer
2) Patients with NSCLC (advanced stage or recurrent disease) previously treated with chemotherapy
3) Performamne status of 0 or 2
4) 20 years of age or older
5) The presence of mesurable lesions by RECIST
6) Cases survival of 8 weekss or more is expected
7) Written informed consents
8) Adequate organ funcion
White blood cell count >= 3,000 /mm3
Neutrophil count >= 1,500 /mm3
Hemoglobin >= 9.0 g/dL
Platelet count >= 100,000 /mm3
AST and ALT x 2.5 of upper limit of normal (ULN) or less
Total bilirubin <or= 1.5 mg/dL
Serum creatinine x 1.5 of upper limit of normal (ULN) or less
Pao2 >= 60 torr or SPo2 >= 95%
9) Interval from previous chest radiotherapy: more than 12 weeks after the last irradiation to lung (paliative radiation to bone is excluded)
10) Interval from previous treated with intrapleural therapy for malignant pleural effusion: more than 1 week
11) Interval from previous chemotherapy: more than 1 week

Key exclusion criteria

1) Interstitial pneumonia or pulmonary fibrosis detectable on X ray
2) Severe concurrent disease (Ischemic heart disease requiring treatment, hepatic failure, hemorrhagic peptic ulcer, poorly controlled diabetes)
3) Severe infection
4) History of active double cancer within 5 years prior to the study
5) Sympyomatic brain metastasis
6) Massive pleural effusion requiring treatment
7) Patients who are pregnant,considering pregnancy oractaing
8) Other conditions not suitable forthis study

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Kageaki Taima

Organization

Hirosaki University Graduate School of Medicine

Division name

Department of Cardiology, Respiratory Medicine and Nephrology

Zip code

Address

5 Zaifu-cho, Hirosaki, 036-8562 Japan

TEL

0172-39-5057

Email

taima0305@hotmail.com

Name of contact person

1st name
Middle name
Last name	Hisashi Tanaka

Organization

Hirosaki University Graduate School of Medicine

Division name

Department of Cardiology, Respiratory Medicine and Nephrology

Zip code

Address

5 Zaifu-cho, Hirosaki, 036-8562 Japan

TEL

0172-39-5057

Homepage URL

Email

xyghx335@gmail.com

Institute

Hirosaki University Graduate School of 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

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

弘前大学病院（青森県），弘前中央病院（青森県），国立病院機構弘前病院（青森県）
八戸市立市民病院（青森県）

Date of disclosure of the study information

2013

Year

09

Month

11

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

Completed

Date of protocol fixation

2013

Year

06

Month

22

Day

Date of IRB

Anticipated trial start date

2013

Year

08

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

2013

Year

09

Month

10

Day

Last modified on

2015

Year

10

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013674