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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012450
Receipt No. R000014551
Scientific Title Phase II study of continuation maintenance by use of nab-Paclitaxel and Bevacizumab after induction chemotherapy of Carboplatin and nab-Paclitaxel pulse bevacizumab in chemotherapy-naïve patients with Stage IIIB / IV non-squamous and non-small cell lung cancer.
Date of disclosure of the study information 2013/12/02
Last modified on 2018/06/10

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Basic information
Public title Phase II study of continuation maintenance by use of nab-Paclitaxel and Bevacizumab after induction chemotherapy of Carboplatin and nab-Paclitaxel pulse bevacizumab in chemotherapy-naïve patients with Stage IIIB / IV non-squamous and non-small cell lung cancer.
Acronym Phase II of Carboplatin (CBDCA) and nab-Paclitaxel (nab-PTX) pulse bevacizumab (BEV) followed by nab-Paclitaxel and bevacizumab
Scientific Title Phase II study of continuation maintenance by use of nab-Paclitaxel and Bevacizumab after induction chemotherapy of Carboplatin and nab-Paclitaxel pulse bevacizumab in chemotherapy-naïve patients with Stage IIIB / IV non-squamous and non-small cell lung cancer.
Scientific Title:Acronym Phase II of Carboplatin (CBDCA) and nab-Paclitaxel (nab-PTX) pulse bevacizumab (BEV) followed by nab-Paclitaxel and bevacizumab
Region
Japan

Condition
Condition Non-small and non-squamous cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of nab-PTX and BEV after induction by CBDCA and nab-PTX pulse BEV in chemotherapy-naïve patients with Stage IIIB / IV non-squamous and non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival (PFS) from the beginning of maintenance therapy
Key secondary outcomes Response rate (RR) by RECIST, Disease control rate (DCR), Overall survival (OS), Time to treatment failure (TTF), maintenance rate, PFS from the start of induction therapy, Adverse events,

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 CBDCA and nab-PTX pulse BEV followed by nab-PTX pulse BEV
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 I) Eligibility criteria for 1st registration
1) Histologically or cytologically proven non-squamous and non-small cell lung cancer
2) Stage IIIB/IV without indication for radical thoracic irradiation or recurrence after surgical treatment
3) Naive treatment of cytotoxic chemotherapy and recurrence more than 6 months ago after completion of postoperable adjuvant chemotherapy. OK432 pleurodesis for malignant pleural effusion is acceptable for pretreatment.
4)Eastern Cooperative Oncology Group performance status of 0-1
5)Age > or = 20 years
6) Tumor has the evaluable lesion.
7) Adequate organ function, Adequate organ function within 2 weeks
a) Leukocyte count > or = 3,000/mm3
b) Neutrophil count > or = 1,500/mm3
c) Platelet count > or = 100,000/mm3
d) Hemoglobin concentration > or = 9.0 g/dl
e) Total bilirubin level < or = 1.5 mg/dl
f) Aspartate aminotransferase and alanine aminotransferase levels < or = 100 IU/L
g) Serum creatinine levels < or = 1.5 mg/dl
h) Acceptable cardiac function
i) Peripheral neuropathy < or = grade 1
9) Estimating Survival more than 3 months
10)Written informed consent

II) Eligibility Criteria for 2nd registration
1) More than 2 cycles of induction chemotherapy
2) Response criteria of induction chemotherapy achieved more than and equal to SD.
3) Recover within 6 weeks after start of last cycle of induction therapy.
1.PS 0-1
2.Leukocyte count > or = 3,000/mm3
3.Neutrophil count > or = 1,500/mm3
4.Platelet count > or = 100,000/mm3
5.Hemoglobin concentration > or = 8.0 g/dl
6.Total bilirubin level < or = 1.5 mg/dl
7.Aspartate aminotransferase and alanine aminotransferase levels < or = 100 IU/L
8.Serum creatinine levels < or = 1.5 mg/dl
9.Peripheral neuropathy < or = grade 2
10.Hypertension < or = grade 2
11.proteinuria < or = grade 2
12.any bleeding < or = grade 1
13.thromboembolic event absence
Key exclusion criteria 1) Patients with squamous cell lung cancer.
2) History of allergic reaction for agents of present treatment
3) Severe myelosupperssion, renal dysfunction or hepatic dysfunction
4) Active concomitant malignancy except carcinoma in situ, intra-mucosal carcinoma or cancer with more than 5 year disease free
5) Active infection more than and equal to grade 2
6) Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage
7) Patients required for continuing more than and equal to 10 mg/day of steroid therapy
8) A history of significant hemoptysis (> 2.5 mL red blood per episode) within 3 months before enrolment
9) History of thromboembolic events
10) Any history of cerebral, myocardial, and pulmonary infarction
11) Bleeding tendency, blood coagulation disorder
12) Other ineligible for bevacizumab
13) Pregnant status or lactation
14) Uncontrolled psychiatric disease
15) Other ineligible status judged by medical oncologist.
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Takeda
Organization National Center for Global health and Medicine-Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL 03-3202-7181
Email ytakeda@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichiro Takeda
Organization National Center for Global health and Medicine-Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL 03-3202-7181
Homepage URL
Email ytakeda@hosp.ncgm.go.jp

Sponsor
Institute Department of Respiratory Medicine
National Center for Global health and Medicine-Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 慶応義塾大学病院 呼吸器内科 (東京都)
災害医療センター 呼吸器内科 (東京都)
帝京大学医学部附属病院 呼吸器・アレルギー内科 (東京都)
東京医科大学病院 呼吸器・甲状腺外科 (東京都)
東京女子医科大学病院 呼吸器内科 (東京都)
虎の門病院 呼吸器センター内科 (東京都) 
国立国際医療研究センター 呼吸器内科 (東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 12 Month 02 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 Because of slow accrual, this study will not be capable of completion. The study committee decided termination of this study.
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
2013 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 02 Day
Last follow-up date
2018 Year 06 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
2013 Year 12 Month 01 Day
Last modified on
2018 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014551

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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