UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015565 |
|---|---|
| Receipt number | 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 12:32:40 |
* 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
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
r-arai@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018086
