UMIN-CTR Clinical Trial

Public title

Phase II Study of Docetaxel+Bevacizumab with non-squamous non-small cell lung cancer for patients pretreated with chemotherapy

Acronym

Phase II Study of Docetaxel+Bevacizumab with non-squamous non-small cell lung cancer for patients pretreated with chemotherapy

Scientific Title

Phase II Study of Docetaxel+Bevacizumab with non-squamous non-small cell lung cancer for patients pretreated with chemotherapy

Scientific Title:Acronym

Phase II Study of Docetaxel+Bevacizumab with non-squamous non-small cell lung cancer for patients pretreated with chemotherapy

Region

Japan

Condition

Non-small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of the combination of docetaxel and bevacizumab with non-squamous non-small cell lung cancer for patients pretreated with chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Progression free survival

Key secondary outcomes

Response rate
Overall survival
Safety
PFS,RR,OS,DCR(harboring EGFR mutation or not)

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

Docetaxel+bevacizumab

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 confirmed StageIIIB/IV non-small-cell lung cancer and non-squamous cell carcinoma.

2.Patients who have previously treated one chemotherapy regimen (without docetaxel and bevacizumab.).

3.With one or more measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) ver.1.1.

4.No chemotherapy within 21days
No operation or radiotherapy within 56 days
No pleurodesis, pleural drainage etc. within 28 days

5.Age20<=

6.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

7.Adequate function of vital organs, including normal hematopoietic function, normal liver function and normal renal function as evidenced by the following data:

8.A life expectancy of more than 3 months.

9.All patients provided written informed consent before initiation of study-related procedures.

Key exclusion criteria

1)Symptomatic Brain metastasis or expected bleeding.
2) history of active double cancer within 5 years.
3) Severe infection
4) History of hemoptysis with 2.5mL or more.
5) Continued bloody phlegm.
6) Receiving anticoagulant drug(including Aspirin over 325mg/day).
7) Perforation of the digestive tract or history of the perforation of the digestive tract within the past one year.
8) Severe comorbidity (heart failure Tendency to hemorrhages uncontrollable hypertension, uncontrollable diabetes, etc)
9) Arterial thromboembolism and Venous thromboembolism within the past one year.
10)Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
11) Neuropathy or edema
12) History of hypersensitivity reaction to drugs formulated with polysorbate.
13) Planning of surgery or thoracic radiotherapy during the trial.
14) Major surgical procedure
15) With a history of drug sensitivity.
16) Pregnant or lactating women or those who declined contraception.
17) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Target sample size

22

Name of lead principal investigator

1st name
Middle name
Last name	Kiyoshi Mori

Organization

Tochigi Cancer Center

Division name

Division of Thoracic Oncology

Zip code

Address

4-9-13 Yonan, Utsunomiya City, Tochigi, 320-0834

TEL

028-658-5151

Email

kmori@tcc.pref.tochigi.lg.jp

Name of contact person

1st name
Middle name
Last name	Takashi Kasai

Organization

Tochigi Cancer Center

Division name

Division of Thoracic Oncology

Zip code

Address

4-9-13 Yonan, Utsunomiya City, Tochigi, 320-0834

TEL

028-658-5151

Homepage URL

Email

takasai@tcc.pref.tochigi.lg.jp

Institute

Tochigi Cancer Center

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

2011

Year

02

Month

14

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

2011

Year

01

Month

10

Day

Date of IRB

Anticipated trial start date

2011

Year

01

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

2011

Year

02

Month

14

Day

Last modified on

2015

Year

08

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006037