UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009966
Receipt number R000011672
Scientific Title A Multicenter phase II study of Docetaxel combined with Bevacizumab after platinum-based chemotherapy in patients with advanced non-squamous non-small cell lung cancer.
Date of disclosure of the study information 2013/02/06
Last modified on 2013/02/06 16:51:03

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Basic information

Public title

A Multicenter phase II study of Docetaxel combined with Bevacizumab after platinum-based chemotherapy in patients with advanced non-squamous non-small cell lung cancer.

Acronym

Phase II study of Docetaxel plus Bevacizumab after platinum-based chemotherapy in patients with advanced non-squamous NSCLC.

Scientific Title

A Multicenter phase II study of Docetaxel combined with Bevacizumab after platinum-based chemotherapy in patients with advanced non-squamous non-small cell lung cancer.

Scientific Title:Acronym

Phase II study of Docetaxel plus Bevacizumab after platinum-based chemotherapy in patients with advanced non-squamous NSCLC.

Region

Japan


Condition

Condition

Non-squamous non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of docetaxel plus bevacizumab for advanced non-squamous NSCLC patients after platinum-based chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression free survival

Key secondary outcomes

Safety, Response rate, Overall survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Docetaxel and bevacizumab will be administered triweekly until disease progression.

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


 Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Written informed consent
(2) It is judged by investigators to be treatable in this protocol
(3) Radical radiation therapy cannot adapt (case of clinical stage of a disease IIIB, IV). After failure to first line therapy, platinum doublet
* EGFR-TKI is not regard as a series of first line therapy
* Previously treated with one cytotoxic chemotherapy regimen
* Palliative radiation therapy (gamma-knife, hole brain irradiation, or irradiation to a bone metastatic ) to any place other than the original lesion genesis can register if there is it more than 2 weeks after the radiation therapy(registration is possible from day 15 as day0 on last treatment day)
(4) age>=20years
(5) With measurable lesion(RECIST version 1.1)
(6) ECOG PS 0-2
(7) Adequate organ function WBC >=3,000/mm3,&not; Neu >=1,500/mm3, Platelet >=100,000/mm3 ,Hb >=8.5 g/dl ,ALT,AST <=2.5 x the Upper Limits of Normal (ULN)
(liver metastasis<=5.0 x ULN), T-bilirubin<=1.5 mg/dl , CCr-50 ml/min (Cockcroft & Gault),
ECG (within normal limit) ,SpO2>=94% , Urine protein<= 1+ or 2 g in urine collection for 24h
(8) Life expectancy more than 3 months

Key exclusion criteria

(1) Squamous metastasis
(2) No prior platinum-based chemotherapy as first- line therapy
(3) No prior docetaxel or bevacizumab as first- line therapy
(4) Having serious complications.
ex): a serious heart disease , cerebrovascular disorder, diabetes that it is hard to control or hypertention , a severe infection, pulmonary fibrosis, interstitial pneumonia, respiratory failure, bleeding, a large quantity of hydrothorax or abdominal dropsy retention, peptic ulcer of the activity, serious nerve disease
(5) Symptomatic brain metastasis
(6) With pulmonary cavitary lesions
(7) Have an anamnesis and the complications , expectoration of fresh blood more than 2.5 ml due to non-small-cell lung cancer
(8) Having an anamnesis of the following bloody phlegm or complications
* there is the dosage career when bloody phlegm occurring continuously (more than one week) or the anamnesis or the internal use styptic is continuous(the cases that an internal use styptic was necessary for again after having been relieved using an internal use styptic or the bloody phlegm which needs with a history of bloody phlegm, the dosage of the injection styptic to need the dosage or the dosage)
(9) Uncontrollable hypertension
(10) Current or previous (within the last 1 year) history of GI perforation
(11) The operation has been scheduled for the examination period
(12) Have multiple primary cancer
(13) History of serious drug hypersensitivity
(14) Pregnancy or lactation
(15) Active psychological disease
(16) Patients who have received a radiation therapy in chest
(17) Receives the steroid continuously(p.o. or i.v.)
(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

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiromasa Inoue

Organization

Graduate School of Medical and Dental Sciences, Kagoshima University

Division name

Pulmonary medicine

Zip code


Address

8-35-1 Sakuragaoka Kagoshima, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Hironobu Kanazawa

Organization

Graduate School of Medical and Dental Sciences, Kagoshima University

Division name

Pulmonary medicine

Zip code


Address

8-35-1 Sakuragaoka Kagoshima, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Pulmonary Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 02 Month 06 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2012 Year 12 Month 28 Day

Date of IRB


Anticipated trial start date

2013 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 02 Month 05 Day

Last modified on

2013 Year 02 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011672


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name