UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015565
Receipt No. R000018086
Scientific Title Phase II study of nab-paclitaxel in combination with carboplatin in patients with refractory small-cell lung cancer
Date of disclosure of the study information 2014/10/30
Last modified on 2014/10/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II study of nab-paclitaxel in combination with carboplatin in patients with refractory small-cell lung cancer
Acronym Phase II study of nab-paclitaxel in combination with carboplatin in patients with refractory small-cell lung cancer
Scientific Title Phase II study of nab-paclitaxel in combination with carboplatin in patients with refractory small-cell lung cancer
Scientific Title:Acronym Phase II study of nab-paclitaxel in combination with carboplatin in patients with refractory small-cell lung cancer
Region
Japan

Condition
Condition Refractory small-cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of nab-paclitaxel in combination with carboplatin in refractory small-cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate (RR)
Key secondary outcomes Disease control rate (DCR), Progression free survival (PFS), Overall survival (OS), and 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 Nab-paclitaxel at the dose of 100mg/m2 (day 1, 8, 15) and carboplatin at the dose of area under curve 5 (day 1) are administered every 3 weeks. Treatment can be continued unless PD or toxicity that is not tolerable is found.
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) Patients with histlogically or cytologically confirmed small cell lung cancer
2) Patients are difficult to treat with adapted drugs to the small cell lung cancer. (patients completed or not acceptable the standard chemotherapy)
3) 20<=, <75 years old
4) Without active cancer other than NSCLC
5) At least one measurable lesion
6) With adequate organ function
neutrophil count => 1,500/mm^3
platelet => 100,000/mm^3
hemoglobin => 9.0g/dL
AST/ALT < 2.5 times less than ULN
T.Bil <= 1.5mg/dL
serum creatinine <= 1.5mg/dL
ECG: without clinically problematic abnormalities
Peripheral neuropathy <= Grade 1
7) Life expectancy of at least 3 months
8) ECOG performance status 0 or 2
9) With written informed consent
Key exclusion criteria 1) Symptomatic brain metastasis
2) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy
3) With active double cancer or multicentric cancer
4) Treated with radiotherapy within the past four weeks.
5) With clinically important complications.
6) With pleural effusion or pericardial effusion accumulates which need drainage
7) With the history of hypersensitivity for nab-paclitaxel, CBDCA
8) Main organs had a serious medical risk factor, and the physicians judged treatment not to be safe.
9) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Ishii
Organization Dokkyo Medical University
Division name Department of Pulmonary Medicine and Clinical Immunology
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-87-2151
Email ishiiysk@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Arai
Organization Dokkyo Medical University
Division name Department of Pulmonary Medicine and Clinical Immunology
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-87-2151
Homepage URL
Email r-arai@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization Dokkyo Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tochigi-kitakan Thoracic Oncology Research Organization (TOTORO)
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 10 Month 30 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 Open public recruiting
Date of protocol fixation
2014 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 30 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 10 Month 30 Day
Last modified on
2014 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018086

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.