UMIN-CTR Clinical Trial

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