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 UMIN000012204
Receipt No. 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 2017/10/14

* 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 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
Email 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
Email yagi-to@mc.pref.osaka.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2013 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 05 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
2013 Year 11 Month 02 Day
Last modified on
2017 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014269

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.