UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003674 |
|---|---|
| Receipt number | R000004456 |
| Scientific Title | A Phase II Study of Carboplatin+weekly Paclitaxel+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous, non-small cell lung cancer. |
| Date of disclosure of the study information | 2010/05/30 |
| Last modified on | 2016/01/17 23:32:07 |
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Basic information
Public title
A Phase II Study of Carboplatin+weekly Paclitaxel+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous, non-small cell lung cancer.
Acronym
Phase II study of CBDCA+weekly PTX+Bev in chemo-naive patients with stage IIIB and IV non-sq, non-small cell lung cancer.
Scientific Title
A Phase II Study of Carboplatin+weekly Paclitaxel+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous, non-small cell lung cancer.
Scientific Title:Acronym
Phase II study of CBDCA+weekly PTX+Bev in chemo-naive patients with stage IIIB and IV non-sq, non-small cell lung cancer.
Region
| Japan |
Condition
Condition
non-squamous, non-small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Carboplatin + weekly Paclitaxel + Bevacizumab in chemo-naive stageIIIB and IV 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
Assessment
Primary outcomes
response rate
Key secondary outcomes
progression free survival, overall survival, time to progression, safety
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
Patients receive CBDCA(AUC 6,div), Bevacizumab (15mg/kg,div) on day 1 and paclitaxel (70mg/m2,div) on day 1,8,15 every 4 weeks,threee to six cycles. Patients who achieve disease control (response or stable disease) without unacceptable toxicity receive Bevacizumab(15mg/kg,div) on day 1, every three weeks, until disease progression.
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
1)histologically or cytologically comfirmed non-squamous*, non-small cell lung cancer
*Cases with histological diagnosis of non-small cell lung cancer only, and/or cases with non-small cell
lung cancer with less than 50% of squamous components will be applicable.
2)Stage IIIB/IV(UICC-7)or postoperative recurrence NSCLC
3)chemo-naive patients
*post-operative therapy with oral UFT is applicable.
4)patients aged 20 years or older
5)ECOG performance status of 0 or 1
6)Measurable by RECIST(ver 1.1)criteria.
7)Patients who has the following periods:
palliative radiotherapy(thorax excluded), 2 weeks;
operation, 4 weeks;
chest drainage, 2 weeks;
biopsy with incision, port custody,and treatment to injury, 2weeks;
aspiration biopsy cytology, 1 week
8)adequate bone marrow,liver,and renal functions:
neutorophil >=1,500/mm3; platelet >=100,000/mm3;
Hb >=9.0 g/dl;
AST and ALT <2.5x of upper limit of normal (ULN);
total bilirubin <=1.5x of upper limit of normal(ULN);
serum creatinin <=1.2 mg/dl;
SpO2>90;
PT-INT <1.5;
urinari protein <=1+or 2g/24h
9)a life expectancy of 3 months or more
10)Written informed consent
Key exclusion criteria
1)Uncontrolled infection or serious medical complications
2)massive,pleural effusion or ascites(accept controrable pleural effusion with OK-432)
3)current nervous symptom
4)severe cardiac disease
5)current or previous histoty of hemoptysis(2.5ml)due to NSCLC
6)history of hemoptysis(over 1week) or receive oral/i.v. hemostatic drug
7)uncontrolled hypertension
8)Patients with active lung disease such as interstitial pneumonia,radiation pneumonitis,plumonary infection,or drug-induced lung damage
9)current or previous (within the last 1 year)history of GI perforation
10)history of myocardial infarction and cerebral infarction
11)history of drug allergy
12)active concomitant malignancy
13)pregnant or lactating women or those who declined contraception
14)those judged to be not suitable by the attending physician
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Yokoyama |
Organization
Kochi University, School of Medicine
Division name
Dept of Hematology and Respiratory Medicine
Zip code
Address
Kohasu, Okocho, Nankoku city, Kochi
TEL
088-880-2345
im62@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kubota |
Organization
Kochi University, School of Medicine
Division name
Dept of Hematology and Respiratory Medicine
Zip code
Address
Kohasu, Okocho, Nankoku city, Kochi
TEL
088-880-2345
Homepage URL
kubotat@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University, School of Medicine, Department of Hematology and Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Secondary IDs
Secondary IDs
NO
Study ID_1
22-9
Org. issuing International ID_1
Kochi University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
高知大学医学部附属病院（高知県）、高知医療センター（高知県）、国立病院機構高知病院（高知県）、近森病院（高知県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://ar.iiarjournals.org/content/36/1/307.long
Number of participants that the trial has enrolled
Results
Aim: The present study aimed to evaluate the effectiveness and safety of weekly paclitaxel (PTX) combined with carboplatin (CBDCA) plus bevacizumab (BEV), followed by maintenance BEV in patients with advanced NSCLC. Patients and Methods: Patients with unresectable stage IIIB and IV NSCLC (n=43) were treated with CBDCA (AUC 6, day 1), BEV (15 mg/kg, day 1), and PTX (70 mg/m2, days 1, 8, 15) intravenously every 4 weeks, for 3 to 6 cycles, followed by maintenance BEV (15 mg/kg) every 3 weeks. Results: The objective response rate and disease control rate were 67.4% and 90.7%, respectively. The median progression-free survival was 7.6 months. The median overall survival was 17.7 months. Common adverse events were tolerable bone marrow suppression, fatigue, hypertension, and nasal bleeding. Conclusion: Weekly administration of PTX combined with CBDCA plus BEV therapy was effective, and well-tolerated by advanced NSCLC patients.
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
Completed
Date of protocol fixation
| 2010 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 30 | Day |
Last modified on
| 2016 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004456
