UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006152 |
|---|---|
| Receipt number | R000007278 |
| Scientific Title | Phase I/II study of Docetaxel with Bevacizumab for refractory and geriatric non-squamous non-small cell lung cancer |
| Date of disclosure of the study information | 2011/08/15 |
| Last modified on | 2012/06/15 16:57:40 |
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Basic information
Public title
Phase I/II study of Docetaxel with Bevacizumab for refractory and geriatric non-squamous non-small cell lung cancer
Acronym
Phase I/II study of Docetaxel with Bevacizumab for refractory and geriatric non-squamous non-small cell lung cancer
Scientific Title
Phase I/II study of Docetaxel with Bevacizumab for refractory and geriatric non-squamous non-small cell lung cancer
Scientific Title:Acronym
Phase I/II study of Docetaxel with Bevacizumab for refractory and geriatric non-squamous non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non-Squamous Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the recommended dose , efficacy and safety of Docetaxel with Bevacizumab for geriatric and refractory 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 I,II
Assessment
Primary outcomes
Phase I : Recommended dose of docetaxel in combination with bevacizumab
Phase II : Progression Free Survival
Key secondary outcomes
Phase I
Safety
Phase II
Response Rate
Disease Control Rate
Overall Survival
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
Docetaxel with Bevacizumab
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 confirmed Stage IIIB/IV non-squamous non-small cell lung cancer
2) 70<= years
3) Previously treated one chemotherapy regimen (without Docetaxel)
4) With one or more measurable disease based on RECIST (ver.1.1)
5) No chemotherapy within 21days prior to the study.
6) Performance Status (ECOG) : 0-2
7) Adequate function of vital organs, including normal hematopoietic liver
and renal function as following:
WBC >= 3,000/mm3
Neutrophils >= 1,500/mm3
Hemoglobin >= 9.0 g/dL
Platelets >= 75,000/mm3
AST and ALT < 100IU/I
Total bilirubin <= 1.5mg/mL
Serum creatinine <= 1.5mg/dL
PT-INR <1.5
Urinary protein <= 1+
8) A life expectancy of more than 3 months
9) Written informed consent before initiation of study-related procedures
No operation or radiotherapy within 56days prior to the study.
No pleurodesis, pleural drainage etc. within 28days prior to the study
Key exclusion criteria
1) Symptomatic brain metastasis
2) History of active double cancer within 5 years prior to the study
3) Severe infection
4) History of hemoptysis with 2.5mL or more
5) Continued bloody phlegm
6) Receiving anticoagulant drug(including Aspirin over 325mg/day)
7) Perforation of the digestive tract or history of the perforation of the digestive tract within the past one year.
8) Severe comorbidity (heart failure Tendency to hemorrhages uncontrollable hypertension, uncontrollable diabetes, etc)
9) Arterial thromboembolism and Venous thromboembolism within the past one year.
10)Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
11) Neuropathy or edema
12) History of hypersensitivity reaction to drugs formulated with polysorbate.
13) Planning of surgery or thoracic radiotherapy during the trial.
14) Uncured major wound
15) With a history of drug sensitivity for Taxotere injection or Avastin injection.
16) No abnormal findings requiring treatment in the electrocardiogram
17) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Okada |
Organization
Chiba Tokushukai Hospital
Division name
Department of Thoracic Surgery and Medicine
Zip code
Address
1-27-1, Narashinodai, Funabashi-City, Chiba, 274-8503, Japan
TEL
047-466-7111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Okada |
Organization
Chiba Tokushukai Hospital
Division name
Department of Thoracic Surgery and Medicine
Zip code
Address
1-27-1, Narashinodai, Funabashi-City, Chiba, 274-8503, Japan
TEL
047-466-7111
Homepage URL
Sponsor or person
Institute
Chiba Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉徳洲会病院（千葉県）
茅ヶ崎徳洲会総合病院（神奈川県）
湘南鎌倉総合病院（神奈川県）
八尾徳洲会総合病院（大阪府）
大隅鹿屋病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 15 | 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 | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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 | 08 | Month | 12 | Day |
Last modified on
| 2012 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007278
