UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004573
Receipt number R000005455
Scientific Title Phase II trial of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer
Date of disclosure of the study information 2010/11/17
Last modified on 2014/04/24 11:56:31

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Basic information

Public title

Phase II trial of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer

Acronym

Phase II trial of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer

Scientific Title

Phase II trial of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer

Scientific Title:Acronym

Phase II trial of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer

Region

Japan


Condition

Condition

Non-small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the efficacy of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Three-months progression free rate

Key secondary outcomes

Overall response rate
Overall survival
Toxicity


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Paclitaxel at a dose of 200mg/m2 and bevacizumab 15mg/kg were administrated every 21 days until disease progression, unacceptable toxicity, patient refusal, alternate treatment, or investigator's decision to remove patient from study.

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Non-squamous non-small-cell lung cancer with histologic or cytologic evidence.
2) Clinical stage IV
3) Previously treated with more than one systemic chemotherapy
4) Age >=20, <75
5) ECOG performance status <=2
6) Adequate organ functions like below
WBC >=3000/mm3
Neutrophil count >=1500/mm3
Platelet count >=100000/mm3
Serum creatinine <=1.2mg/dl
Total bilirubin <=1.5mg/dl
AST <=80IU/l
ALT <=80IU/l
PaO2 >=60Torr or SpO2 >90%
7) Written informed consent

Key exclusion criteria

1) Previously treated with paclitaxel and / or bevacizumab
2) Patients with brain metastasis
3) Patients with hemoptysis
4) Patients receiving therapeutic anticoagulation
5) Patients with complications like below
Active infection
Acute myocardial infarction during recent 6 months or the other severe heart disease
Uncontrollable diabetes mellitus
Uncontrollable hypertension
Active psychological disease
6) Hypersensitivity to paclitaxel and / or bevacizumab
7) Active concomitant malignancy
8) Pregnancy or lactation
9) Inappropriate patients for this study judged by the physicians

Target sample size

42


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shintaro Kanda

Organization

Shinshu University School of Medicine

Division name

First Department of Internal Medicine

Zip code


Address

3-1-1 Asahi, Matsumoto, Nagano 390-8621 Japan

TEL

0263-37-3631

Email

shintarokanda@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Shintaro Kanda

Organization

Shinshu University School of Medicine

Division name

First Department of Internal Medicine

Zip code


Address

3-1-1 Asahi, Matsumoto, Nagano 390-8621 Japan

TEL

0263-37-3631

Homepage URL


Email

shintarokanda@gmail.com


Sponsor or person

Institute

First Department of Internal Medicine, Shinshu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

First Department of Internal Medicine, Shinshu University School of Medicine

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

2010 Year 11 Month 17 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

Terminated

Date of protocol fixation

2010 Year 11 Month 16 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date

2014 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 11 Month 16 Day

Last modified on

2014 Year 04 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005455


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name