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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006525
Receipt No. R000007684
Scientific Title Phase2 Trial of Carboplatin-Paclitaxel bi-weekly and Bevacizumab combination therapy for Elderly Patients With Nonsquamous Non-Small-Cell Lung Cancer
Date of disclosure of the study information 2011/10/12
Last modified on 2013/06/19

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Basic information
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
Condition Nonsquamous Non-Small-Cell Lung Cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
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

Assessment
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)

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 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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Shimane University, School of Medicine
Institute
Department

Funding Source
Organization Shimane 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 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

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 12 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
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
Other related information

Management information
Registered date
2011 Year 10 Month 12 Day
Last modified on
2013 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007684

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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