UMIN-CTR Clinical Trial

Basic information
Public title	Weekly Paclitaxel in Combination with Bevacizumab in Patients with Non-Squamous Non-Small Cell Lung Cancer Previously Untreated -A Phase II study-
Acronym	Weekly Paclitaxel in Combination with Bevacizumab in Patients with Non-Squamous Non-Small Cell Lung Cancer Previously Untreated -A Phase II study-
Scientific Title	Weekly Paclitaxel in Combination with Bevacizumab in Patients with Non-Squamous Non-Small Cell Lung Cancer Previously Untreated -A Phase II study-
Scientific Title:Acronym	Weekly Paclitaxel in Combination with Bevacizumab in Patients with Non-Squamous Non-Small Cell Lung Cancer Previously Untreated -A Phase II study-
Region	Japan

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

Objectives
Narrative objectives1	To evaluate safety and efficacy of weekly Paclitaxel in combination with Bevacizumab in patients with non-squamous non-small cell lung cancer previously untreated
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Safety, Disease control rate, Overall response rate, Time to treatment failure, Overall survival

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	Weekly Paclitaxel in combination with Bevacizumab in patients with non-squamous non-small cell lung cancer previously untreated
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)Histological or cytological diagnosis of non-squamous NSCLC (2)Provided written consent in person for participation in this study (3)Age 20 years or older (4)ECOG Performance Status (PS) 0 to 2 (5)Life expectancy of more than three months (6)Have measurable lesions according to the Response Evaluation Criteria in Solid Tumors ver1.1 (7)Have adequate function of major organs (bone marrow, liver, kidneys) defined as follows: Neutrophils>=1,500 /mm3 Platelets>=100,000 /mm3 Hemoglobin>8.0 g/dl AST and ALT<=100IU/l Serum creatinine<=1.5 mg/dl (8)one prior chemotherapy excluded adjuvant chemotherapy, EGFR-TKI and ALK inhibitor (9)no administration of Paclitaxel previously
Key exclusion criteria	(1)Received transfusion or G-CSF within 14 days prior to enrollment (2)Urine protein>=2+ (3)History of drug allergy (4)Active multiple cancers (5)Severe infection (6)High fever (7)Abnormal cardiac function (8)Severe pulmonary disease; Interstitial pneumonia, severe COPD, pulmonary thromboembolism (9)History of hematoemesis, ileus and gastroduodenal ulcer (10)Need for drainage of pleural effusion, acsites or pericardial effusion (11)Medically uncontrolled thromboembolism (12)Symptomatic CNS metastases previously untreated (13)CNS or Psychological disorders (14)Medically uncontrolled hypertension or diabetes mellitus (15)Nonhealing wound and surgery within 4 weeks before treatment (16)History of hemoptysis; one-half teaspoon of bright red blood per event (17)Recent use of aspirin (>=325 mg/day) (18)Severe bone marrow suppression (19)Pregnancy or lactation
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Middle name Last name Eiji Shimizu
Organization	Faculty of Medicine, Tottori University
Division name	Division of Medical Oncology and Molecular Respirology
Zip code
Address	36-1 Nishi-machi, Yonago, Tottori
TEL	0859-38-6537
Email	eiji@med.tottori-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masahiro Kodani
Organization	Faculty of Medicine, Tottori University
Division name	Division of Medical Oncology and Molecular Respirology
Zip code
Address	36-1 Nishi-machi, Yonago, Tottori
TEL	0859-38-6537
Homepage URL
Email	kodani@med.tottori-u.ac.jp

Sponsor
Institute	Division of Medical Oncology and Molecular Respirology, Faculty of Medicine, Tottori University
Institute
Department

Funding Source
Organization	Division of Medical Oncology and Molecular Respirology, Faculty of Medicine, Tottori University
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	鳥取大学医学部附属病院(鳥取県)、鳥取県立中央病院(鳥取県)、松江赤十字病院(島根県)、米子医療センター(鳥取県)、松江医療センター(島根県)、松江市立病院(島根県)

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 23 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	Completed
Date of protocol fixation	2014 Year 06 Month 23 Day
Date of IRB	2014 Year 06 Month 16 Day
Anticipated trial start date	2014 Year 06 Month 23 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 06 Month 23 Day
Last modified on	2019 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016698