UMIN-CTR Clinical Trial

Public title

A phase II study of Docetaxel with Bevacizumab for previously treated non-squamous non-small cell lung cancer.

Acronym

A phase II study of Docetaxel with Bevacizumab for previously treated non-squamous non-small cell lung cancer.

Scientific Title

A phase II study of Docetaxel with Bevacizumab for previously treated non-squamous non-small cell lung cancer.

Scientific Title:Acronym

A phase II study of Docetaxel with Bevacizumab for previously treated non-squamous non-small cell lung cancer.

Region

Japan

Condition

non-squamous non-small cell lung cancer.

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

A phase II study of Docetaxel with Bevacizumab for previously treated non-squamous non-small cell lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Progression Free Survival

Key secondary outcomes

Response Rate
Overall Survival
Safety Profile

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 with 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 or cytologically confirmed non-squamous non-small cell lung cancer.
2. Clinical stage IIIB/IV NSCLC without any indications for radiotherapy or surgery.
3. Relapsed or progressed to one prior treatment with a platinum-based chemotherapy on the image.
4. Relapsed or progressed to only one prior chemotherapy (A patient with history of treatment with EGFR-TKI or UFT as adjuvant regimen is eligible.)
5. No chemotherapy (or EGFR-TKI)within 4wks prior to the study.
6.No Surgery within 4wks prior to the study.
7. No radiotherapy within 2wks prior to the study.
8. With one or more measurable disease based on RECIST.
9. 20<= years.
10. Performance status (ECOG) : 0-2.
11. Adequate function of vital organs as following:
WBC >= 3,000/mm3
Neutrophils >= 1,500/mm3
Platelets >= 100,000/mm3
Hemoglobin >= 9.0 g/dL
AST and ALT <= 2.5ULN
Total bilirubin <= 1.5ULN
Serum creatinine <= 1.5mg/dL
PaO2<=60mmHg or SpO2<=93%
12. A life expectancy of more than 3 months.
13. Written informed consent before initiation of study-related procedures.

Key exclusion criteria

1. Prior treatment with Docetaxel.
2. History or complication of hemoptysis with 2.5mL per time or more.
3.Patients with lesions at risk of causing hemoptysis in hilar by chest CT.
4. Invasion to major vessel of tumor.
5. Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
6.Have uncontrolled effusion (Pleural, peritoneal effusion, or cardiac effusion which requires drainage for symptom management).
7. Planning of concurrent thoracic radiotherapy (including if radiation field does not cover the chest).
8. Have active CNS metastases.
9. Have another active malignancy.
10. Major surgery within 4wks prior to the study.
11. Urinary protein <= 2+
12. Patients with therapeutic anticoagulopathy.
13. Have a history of serious systemic disease.
14. In pregnancy, during breast feeding, or possibility of pregnancy.
15. With a history of serious drug sensitivity.
16. Mental disease or psychotic manifestation.
17. Severe infection such as having a HCV Ab positive or HbsAg positive.
18. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Isao Goto

Organization

Osaka Medical College

Division name

First Department of Internal Medicine,

Zip code

Address

2-7,Daigaku-machi Takatsuki-city Osaka 569-8686 JAPAN

TEL

072-683-1221

Email

Name of contact person

1st name
Middle name
Last name	Yosuke Tamura

Organization

Osaka Medical College

Division name

First Department of Internal Medicine

Zip code

Address

2-7,Daigaku-machi Takatsuki-city Osaka 569-8686 JAPAN

TEL

072-683-1221

Homepage URL

Email

Institute

First Department of Internal 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

Date of disclosure of the study information

2012

Year

08

Month

20

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

2012

Year

04

Month

24

Day

Date of IRB

Anticipated trial start date

2012

Year

08

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

08

Month

14

Day

Last modified on

2016

Year

02

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010206