UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012204 |
|---|---|
| Receipt number | R000014269 |
| Scientific Title | A phase2 study to evaluate the efficacy and safety of weekly nab-paclitaxel in combination with carboplatin in patients with cancer of unknown primary |
| Date of disclosure of the study information | 2013/11/05 |
| Last modified on | 2020/12/19 13:55:18 |
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Basic information
Public title
A phase2 study to evaluate the efficacy and safety of weekly nab-paclitaxel in combination with carboplatin in patients with cancer of unknown primary
Acronym
Efficacy and safety of weekly nab-paclitaxel plus CBDCA in patients with CUP
Scientific Title
A phase2 study to evaluate the efficacy and safety of weekly nab-paclitaxel in combination with carboplatin in patients with cancer of unknown primary
Scientific Title:Acronym
Efficacy and safety of weekly nab-paclitaxel plus CBDCA in patients with CUP
Region
| Japan |
Condition
Condition
cancer of unknown primary (CUP)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients with cancer of unknown primary(CUP) are treated by a combination chemotherapy of weekly nab-paclitaxel and carboplatin(CBDCA) as a first-line chemotherapy. We analyze the efficacy(RR, PFS, OS) and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
progression free survival, overall survival, adverse event
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 is administered as a 30-minute infusion at a dose of 100mg/m2 on days 1,8,and 15 followed by carboplatin at an AUC of 6 mg.min/ml(per Calvert formula) given on day1, every 21 days. Responding patients and patients with stable disease have a six-cycle maximum.
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)Patients with histologically comfirmed metastatic malignant lesion, with no identifiable primary site by physical examination, imaging, and laboratory examination.
2)No indication for radical operation and radiotherapy.
3)Measurable disease according to RECIST(version1.1).
4)No prior chemotherapy for CUP.
5)ECOG scale: 0-1
6)Patient with enough feasibility for planned chemotherapy(hematological, liver, renal, cardiopulmonary function).
7)peripheral neuropathy <= Grade1
8)Patients who are expected to survive for more than 3 months.
9)Written informed consent.
Key exclusion criteria
1)Pregnancy or breast feeding.
2)Patients unable to take nab-paclitaxel and CBDCA because of significant cardiovascular abnormalities, renal dysfunctions, hepatic insufficiency, uncontrolled diabetes, uncontrolled hypertension, bleeding tendency, active interstitial pneumonia,etc.
3)Known HIV, active hepatitis B, active hepatitis C, and/or other known severe infections, including but not limited tuberculosis.
4)Ascites, pleural effusion, pericardial effusion, which require regular drainage.
5)Any other active malignancy unless free of disease for at least five years.
6)Known active brain metastasis.
7)Known hypersensitivity to any of platinum drugs, paclitaxel, and albumin containing drugs.
8)Specific clinicopathologic subgroups which have effective management.
a)Woman with isolated axillary lymph node metastasis.
b)Patients with CUP presenting as metastatic cervical or isolated inguinal lymphadenopathy(squamous cell carcinoma).
c)Men with features of the extra gonadal germ cell cancer syndrome.
d)Men with features of prostate cancer(adenocarcinoma, elevated level of PSA, and osteoblastic bone metastasis).
e)Neuroendcrine tumors.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinari Yagi |
Organization
Osaka International Cancer Institute
Division name
Department of Clinical Oncology
Zip code
Address
3-1-69 Otemae, Chuo-ku,Osaka 541-8567 Japan
TEL
06-6945-1181
yagi-to@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshinari Yagi |
Organization
Osaka International Cancer Institute
Division name
Department of Clinical Oncology
Zip code
Address
3-1-69 Otemae, Chuo-ku,Osaka 541-8567 Japan
TEL
06-6945-1181
Homepage URL
yagi-to@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
大阪国際がんセンター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 05 | 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
| 2013 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 10 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 20 | Day |
Other
Other related information
This clinical trail was discontinued due to poor patient enrollment.
Management information
Registered date
| 2013 | Year | 11 | Month | 02 | Day |
Last modified on
| 2020 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014269
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