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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013310
Receipt No. R000015526
Scientific Title Phase II Study of Nab-paclitaxel and Carboplatin Plus Bevacizumab as First-Line Chemotherapy for Reccurent or stage IIIB and IV Nonsquamous Non-Small-Cell Lung Cancer (ALCT004)
Date of disclosure of the study information 2014/03/03
Last modified on 2015/09/04

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Basic information
Public title Phase II Study of Nab-paclitaxel and Carboplatin Plus
Bevacizumab as First-Line Chemotherapy for Reccurent or stage IIIB and IV Nonsquamous
Non-Small-Cell Lung Cancer (ALCT004)
Acronym Phase II Study of Nab-PTX and CBDCA Plus
Bev With Maintenance Bev As First-Line Chemotherapy for Reccurent or Advanced Non-sq NSCLC (ALCT004)
Scientific Title Phase II Study of Nab-paclitaxel and Carboplatin Plus
Bevacizumab as First-Line Chemotherapy for Reccurent or stage IIIB and IV Nonsquamous
Non-Small-Cell Lung Cancer (ALCT004)
Scientific Title:Acronym Phase II Study of Nab-PTX and CBDCA Plus
Bev With Maintenance Bev As First-Line Chemotherapy for Reccurent or Advanced Non-sq NSCLC (ALCT004)
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 To evaluate efficacy and safety of carboplatin plus nab-paclitaxel and bevacizumab in previously untreated stageIIIB/VI or postoperative recurrence non-squamous non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes overall survival,progression free survival, safety,QOL

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Nab-paclitaxel(100mg/m2) on day1,8,15 plus carboplatin (AUC 6) and bevacizumab(15 mg/kg) on day1 given every 4 weeks for 4 cycles(max 6cycles). For patients with response or stable disease, bevacizumab(15mg/kg) on day1 every 3 weeks were continued until disease progression or unacceptable toxicity.
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
75 years-old >
Gender Male and Female
Key inclusion criteria (1)Eligibility criteria for induction
1) Histologically or cytologically comfirmed non-squamous, non-small cell lung cancer
2) Stage IIIB/IV or postoperative recurrence Non-Sq NSCLC
3) Chemo-naive patients (contain EGFR-TKI and ALK-TKI)
* Recurrence more than 6 months ago after completion of postoperable adjuvant chemotherapy is acceptable.
* OK432 pleurodesis for malignant pleural effusion is acceptable.
4) Palliative radiotherapy (thorax excluded)
5) At least one measureable lesion per RECIST 1.0
6) Patients aged 20 or older, 75 under
7) ECOG performance status of 0 or 1
8) Adequate organ function within 2 weeks
* Leukocyte count > or = 3,000/mm3
* Neutrophil count > or = 1,500/mm3
* Platelet count > or = 100,000/mm3
* Hemoglobin concentration > or = 9.0 g/dl
* AST and ALT levels < or = 100IU/L
* Total bilirubin level < or = 1.5mg/dl
* Serum creatinine levels < or = 1.2mg/dl
* SpO2 > or = 92% (room air)
* Urinary protein < or = 1+
* Acceptable cardiac function
* Peripheral neuropathy < or = grade 1
9)Estimating Survival more than 3 months
10)Written informed consent

(2)Eligibility Criteria for maintenance therapy
1)Recover within 43 days after start of last cycle of induction therapy.
2)More than 3 cycles of induction chemotherapy and response criteria of induction chemotherapy achieved more than and equal to SD.
3)ECOG performance status of 0 or 1
4) Adequate organ function within 2 weeks
* Neutrophil count > or = 1500/mm3
* Hemoglobin concentration > or = 8.0 g/dl
* Platelet count > or = 100000/mm3
* AST and ALT levels < or = 100IU/L
* Total bilirubin level < or = 1.5mg/dl
* Serum creatinine levels < or = 1.5mg/dl
* SpO2 > or = 92% (room air)
* Peripheral neuropathy < or = grade 2
* Hypertension < or = grade 2
* proteinuria < or = grade 2
* any bleeding < or = grade 1
* thromboembolic event absence
Key exclusion criteria 1)SVC synd
2)Active concomitant malignancy except carcinoma in situ, intra-mucosal carcinoma or cancer with more than 5 year disease free
3)Severe active infection and sever complication (gastrointestinal hemorrhage,cardiac disease)
4)Pregnant status or lactation
5)Uncontrolled psychiatric disease
6)History of allergic reaction for agents of present treatment
7)Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage
8)A history of significant hemoptysis (> 2.5 mL red blood per episode) before enrolment
9)Evidence of tumor invading large vessel on imaging, cavity and thrombus
10)History of thromboembolic events.Any history of cerebral, myocardial, and pulmonary infarction
11)Symptomatic brain metastasis
12)History of operation and biopsy within 4 weeks
13)Need to antiplatelet therapy or anticoagulation therapy without Aspirin 324 mg/day within 10 days
14)Bleeding tendency, blood coagulation disorder
15)Bowel obstruction
16)Current or previous history of gastrointestinal perforation and diverticulitis
17)Pulmonary fibrosis and interstitial pneumonia on chest X-ray or symptomatic pulmonary fibrosis and interstitial pneumonia
18)Uncontrolled hypertension and diabetes
19)Other ineligible status judged by medical oncologist
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuama Yokoyama
Organization Kyorin University School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 6-20-2 Shinkawa, Mitaka, Tokyo, Japan
TEL 0422-47-5511
Email taku@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuma Yokoyama
Organization Kyorin University School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 6-20-2 Shinkawa, Mitaka, Tokyo, Japan
TEL 0422-47-5511
Homepage URL
Email taku@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin University School of Medicine
Institute
Department

Funding Source
Organization Kyorin University School of Medicine
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
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

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 03 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 Enrolling by invitation
Date of protocol fixation
2013 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2013 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
2014 Year 03 Month 02 Day
Last modified on
2015 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015526

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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