UMIN-CTR Clinical Trial

Public title

Phase2 Trial of Carboplatin-Paclitaxel bi-weekly and Bevacizumab combination therapy for Elderly Patients With Nonsquamous Non-Small-Cell Lung Cancer

Acronym

Phase2 Trial of Carboplatin-Paclitaxel bi-weekly and Bevacizumab combination therapy for Elderly Patients With Nonsquamous Non-Small-Cell Lung Cancer

Scientific Title

Phase2 Trial of Carboplatin-Paclitaxel bi-weekly and Bevacizumab combination therapy for Elderly Patients With Nonsquamous Non-Small-Cell Lung Cancer

Scientific Title:Acronym

Phase2 Trial of Carboplatin-Paclitaxel bi-weekly and Bevacizumab combination therapy for Elderly Patients With Nonsquamous Non-Small-Cell Lung Cancer

Region

Japan

Condition

Nonsquamous Non-Small-Cell Lung Cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

Efficacy and Safety of Carboplatin-Paclitaxel bi-weekly and Bevacizumab combination therapy for Elderly Patients With Nonsquamous Non-Small-Cell Lung Cancer

Basic objectives2

Others

Basic objectives -Others

1.Quality of Life (QOL)survey
2.Exploration of Bevacizumab-biomarker

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response rate with Response Evaluation Criteria In Solid Tumors (RECIST) criteria

Key secondary outcomes

1.Overall Survival
2.Progression-free survival
3.Time to treatment failure
4.Quality of Life(QOL) survey with FACT-L
5.Evaluation of comorbidity and function with CCI and VES-13 survey
6.Safety(adverse outcome)
7.Blood levels of MMP-9 , PIGF and sVEGFR
8.Analysis of polymorphisms in the VEGF gene(VEGF-A/VEGF-R2)

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

Carboplatin AUC=3, intravenous bi-weekly
Paclitaxel 90mg/m2,intravenous bi-weekly
Bevacizumab 15mg/kg, intravenous q4w
Maintenance; Bevacizumab 15mg/kg, intravenous q3w

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

70

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically proven Nonsquamous and Nonsmall cell lung cancer.
2) Patient who has at least one or more measurable lesion by RECIST criteria.
3) 1st line or more than 30 days after last chemotherapy (EGFR-I only) .
4) ECOG performance status (PS): 0-1
5) Patients aged of 70 years or over.
6) Sufficient function of main organ and bone marrow filled the following criteria:
Leukocyte counts, 3,000/mm3 or over. Neutrophil counts, 1,500/mm3 or over.
Platelets, 100,000/mm3 or over.
Hemoglobin, 9.0g/dL or over.
AST and ALT, 150 IU/L or less.
Serum bilirubin, 1.5mg/dl or less.
Serum creatinin, 1.5 mg/dL or less.
Adequate heart function by ECG.
Proteinuria 1+ or less.
7)Provided written informed consent.

Key exclusion criteria

1) Squamous cell carcinoma.
2) Patients with double cancer.
3) Plan on Concurrent Radiotherapy.
4) Patients with active severe infections.
5) Patients with brain metastasis.
6) History of hemoptysis.
7) Cavity in tumor.
8) Have a bleeding diathesis.
9) Concurrent use of steroid therapy.
10) Use of flucytosine.
11) History of thrombosis.
12) Patients with massive uncontrolled pleural or pericardial effusion ,or ascites.
13) Patients with active severe comorbidity disease.
14) Patients with serious drug allergic reactions.
15) Patients with active concomitant pregnancy.
16) Inappropriate patients for this study judged by the physicians.

Target sample size

23

Name of lead principal investigator

1st name
Middle name
Last name	Takmasa Hotta

Organization

Shimane University, School of Medicine

Division name

Division of Clinical Oncology and Respiratory Medicine

Zip code

Address

89-1 Enya,Izumo,Shimane,Japan,693-8501

TEL

0853-20-2581

Email

Name of contact person

1st name
Middle name
Last name	Takmasa Hotta

Organization

Shimane University, School of Medicine

Division name

Division of Clinical Oncology and Respiratory Medicine

Zip code

Address

89-1 Enya,Izumo,Shimane,Japan,693-8501

TEL

0853-20-2581

Homepage URL

Email

takamasa@med.shimane-u.ac.jp

Institute

Shimane University, School of Medicine

Institute

Department

Personal name

Organization

Shimane University, School of Medicine

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

島根大学医学部附属病院,島根県立中央病院,独立行政法人国立病院機構浜田医療センター,熊本大学薬学部

Date of disclosure of the study information

2011

Year

10

Month

12

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

Terminated

Date of protocol fixation

2011

Year

07

Month

25

Day

Date of IRB

Anticipated trial start date

2011

Year

10

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

10

Month

12

Day

Last modified on

2013

Year

06

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007684