UMIN-CTR Clinical Trial

Public title

A randomized phase 2 study of Docetaxel with or without Bevacizumab after platinum-based chemotherapy plus bevacizumab in patients with advanced non-squamous non-small-cell lung cancer

Acronym

A randomized phase 2 study of Docetaxel with or without Bevacizumab after platinum-based chemotherapy plus bevacizumab in patients with advanced non-squamous non-small-cell lung cancer

Scientific Title

A randomized phase 2 study of Docetaxel with or without Bevacizumab after platinum-based chemotherapy plus bevacizumab in patients with advanced non-squamous non-small-cell lung cancer

Scientific Title:Acronym

A randomized phase 2 study of Docetaxel with or without Bevacizumab after platinum-based chemotherapy plus bevacizumab in patients with advanced non-squamous non-small-cell lung cancer

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To assess the efficacy and safety of Docetaxel plus Bevacizumab after failure of platinum-based chemotherapy plus bevacizumab in patients with advanced non-squamous non-small-cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Progression free survival

Key secondary outcomes

Response rate, Overall Survival, Safety

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Docetaxel

Interventions/Control_2

Docetaxel plus Bevacizumab

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) Patients with stage 3b/4 or recurrent non-squamous NSCLC who have progressed on one prior treatment with a platinum-based chemotherapy plus bevacizumab
* A patient who has received pre- or postoperative chemotherapy is eligible if the last administration of the prior adjuvant regimen occurred at least 12 months prior to platinum-based chemotherapy plus bevacizumab.
* A patient with history of treatment with EGFR-TKI (gefitinib or erlotinib) priot platinum-based chemotherapy plus bevacizumab is eligible if the patient had an EGFR mutation
2) Cytologically or histologically documented non-squamous cell carcinoma of the lung
3) More than 21 days since prior chemotherapy
* A patient who has received platinum plus gemcitabine with bevacizumab is eligible if more than 21 days have passed since the last administration of platinum and bevacizumab, and more than 14 days of gemcitabine.
* A patient who has received platinum plus S-1 with bevacizumab is eligible if more than 21 days have passed since the last administration of platinum and bevacizumab, and more than 7 days of S-1.
4) Life expectancy of at least 3 months
5) Age eligible for study: 20 years and above
6) ECOG performance status of 0 to 2
7) Have measurable lesion in a previously non-irradiated area according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
8) Have adequate organ function
9) Provide written informed consent

Key exclusion criteria

1) Prior treatment with docetaxel
2) Have central nervous system metastases (A patient who has previously treated brain metastases, without evidence of progression or hemorrhage at baseline is eligible)
3) Currently have or have a history of hemoptysis (>= one-half teaspoon of bright red blood per event)
4) Clinically significant drug allergy
5) Have a evidence of thrombosis
6) Have a serious concomitant active infection, which needs antibiotics, antimycotic drugs or virucide
7) Have a history of serious systemic disease including: clinically significant cardiovascular disease; medically uncontrolled diabetes and hypertension; gastrointestinal perforation, gastroparesis, or obstruction
8) Uncontrolled effusion (Pleural, peritoneal effusion, or cardiac effusion which requires drainage for symptom management)
Regarding the patient who have or have had pleural effusion;
a) A patients who developed recurrent effusion within two weeks after drainage tube removal is ineligible
b) A patient who received intrapleural chemotherapy (excluding BRM such as OK432) for pleurodesis is ineligible
9) Patients with or with anticipation of invasive procedures as defined below:
a) Major surgery within four weeks of registration
b) Palliative radiotherapy within two weeks of registration
c) Minor surgical procedures, core biopsy or traumatic injury, within two weeks of registration
d) Transfusion of any blood products within two weeks of registration
10) Have another active malignancy
11) Interstitial pneumonia or pulmonary fibrosis documented obviously in chest X ray
12) Mental disease or psychotic manifestation
13) Pregnant or beeast-feeding woman or patient who doesn't agree to contraception
14) Not suitable for participating in the study for any other reason

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Masayuki Takeda

Organization

Kinki University Faculty of Medicine

Division name

Department of Medical Oncology

Zip code

Address

377-2 Ohno-higashi, Osaka-Sayama,Osaka 589-8511, Japan

TEL

072-366-0221

Email

takedamasa2004@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code

Address

Nanma Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka556-0016 JAPAN

TEL

06-6633-7400

Homepage URL

Email

datacenter@wjog.jp

Institute

West Japan Oncology Group

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

2010

Year

12

Month

13

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/26828788

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

2010

Year

11

Month

20

Day

Date of IRB

Anticipated trial start date

2011

Year

02

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

2010

Year

12

Month

13

Day

Last modified on

2016

Year

03

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005610