UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005180 |
|---|---|
| Receipt number | R000006129 |
| Scientific Title | phase II study of panitumumab with irinotecan as third-line treatment for advanced colorectal cancer patients |
| Date of disclosure of the study information | 2011/03/03 |
| Last modified on | 2016/03/04 10:36:22 |
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Basic information
Public title
phase II study of panitumumab with irinotecan as third-line treatment for advanced colorectal cancer patients
Acronym
phase II study of panitumumab with irinotecan as third-line treatment for advanced colorectal cancer patients
Scientific Title
phase II study of panitumumab with irinotecan as third-line treatment for advanced colorectal cancer patients
Scientific Title:Acronym
phase II study of panitumumab with irinotecan as third-line treatment for advanced colorectal cancer patients
Region
| Japan |
Condition
Condition
metastatic colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients with inoperable advanced colorectal cancer, standard treatments refractory or intolerance was to evaluate the antitumor efficacy of panitumumab and irinotecan combination chemotherapy.
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
Safety
Overall survival:OS
Progression free survival:PFS
Tumor shrinkage rate
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
Panitumumab+CPT-11 repeat every 14 days until discontinuance criteria.
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) Colorectal cancer histlogical proven
2) Unresectable
3) KRAS wild type
4) Primary and secondary standard chemotherapies were refractory or intolerance.
5) No prior panitumumab/cetuximab
6) More than 20 years old
Expect to survive more than 3 months
ECOG performance status: 0-2
7) Organs (bone marrow, lung, liver, and kidney) failure is not advanced.
i) Neutrophil count: more than 1,500 / mm3
ii)Platelet: more than 100,000 / mm3
iii)Hemoglobin: more than 8.0g/dl
iv)Serum total bilirubin : less than 2.0 mg / dl
v)Serum creatinine : less tahn 1.5 mg / dl
8) ECG no abnormalities in 28 days before
9) Lesion measured by RECIST in
10) Written patient consent was obtained from patients.
Key exclusion criteria
1) Advanced pleural effusion, ascites
2) CNS metastases
3) Infection
4) Diarrhea (watery stool)
5) Heart disease as a clinical problem
6) Severe complications (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, it is difficult to control diabetes, heart failure, kidney failure, liver failure etc.)
7) Active double cancer
8) Severe mental disorder
9) Irinotecan, oxaliplatin, panitumumab history of hypersensitivity to
10) Treatment with atazanavir sulfate
11) Pregnant and lacting women
12) Severe drug allergy
13) Judged unfit to by doctors in this study
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Rino |
Organization
Yokohama city university
Division name
Department of surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2800
rino@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norio Yukawa |
Organization
Yokohama city university
Division name
Department of surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2800
Homepage URL
nryukawa@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 03 | 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
| 2011 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 03 | Day |
Last modified on
| 2016 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006129
