UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004500 |
|---|---|
| Receipt number | R000004940 |
| Scientific Title | phase 2 trial of panitumumab and irinotecan in previously oxaliplatin and irinotecan refractory patients with colorectal cancer |
| Date of disclosure of the study information | 2010/11/02 |
| Last modified on | 2016/11/08 09:48:37 |
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Basic information
Public title
phase 2 trial of panitumumab and irinotecan in previously oxaliplatin and irinotecan refractory patients with colorectal cancer
Acronym
phase 2 trial of panitumumab and irinotecan
Scientific Title
phase 2 trial of panitumumab and irinotecan in previously oxaliplatin and irinotecan refractory patients with colorectal cancer
Scientific Title:Acronym
phase 2 trial of panitumumab and irinotecan
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of panitumab and irinotecan for patients with K-ras wild, oxaliplatin and irinotecan refractory colorectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
disease control rate, duration of response, progression free survival, overall survival, incidence of adverse events.
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
Patients receive panitumumab and irinotecan until progression.
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) unresectable or recurrent colorectal cancer histlogical proven
2)KRAS wild type in codon 12 and 13 in the primary or metastatic tumor tissue is confirmed
3) disease progression at the irinotecan containing chemotherapy or until 3 months from the last chemotherapy
4) fluorouracil refractory
5) oxaliplatin refractory
6) presence of at least one measurable lesion according to the RECIST
7) ECOG PS 0-2
8) No treatment duration after following treatment
a) radiotherapy 2weeks
b) organ resection 2weeks
c) chemotherapy 2weeks
d) hormone therapy 2weeks
e) cytokine therapy, BRM 2weeks
9) patients have enough organ function for study treatment
1. neutrophil>=1,000/mm3
2. Platelet>=100,000/mm3
3. AST and ALT<=upper limit of normal (ULN)*3 (<=ULN*5 in case of liver metastasis)
4. Total bilirubin<=upper limit of normal (ULN)*3
5. Creatinin <=2.0mg/dL
10) Life expectancy of 8 weeks
11) written informed consent
Key exclusion criteria
1) symptomatic brain metastasis
2) waterly diarrhea
3) Paralytic or mechanical bowel obstruction
4) severe infectious disease
5) severe plumonary disease (interstitial lung disease or plumonary fibrosis)
6) severe complications (uncontrolable diabetes, heart failure NYHA>=III, renal failure, liver failure)
7) Pregnant or lactating women or women of childbearing potential
8) carcinomatosis meningitis
9) peripheral neuropathy Grade>=3
10)Need to treatment with flucytosine, atazanavir sulfate
11) history of Grade>=3 hypersensitivity due to monoclonal antibody therapy
12) history of Grade>=3 hypersensitivity due to irinotecan
13) history of treatment of anti EGFR pathway
14) patients judged inappropriate for this study by physicians
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Fujii |
Organization
Jichi Medical University
Division name
Department of Clinical Oncology
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498
TEL
0285-58-7546
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Nishi |
Organization
Tochigi Cancer Center
Division name
Department of medical oncology
Zip code
Address
4-9-13, Yohnan, Utsunomiya, Tochigi
TEL
028-658-5151
Homepage URL
Sponsor or person
Institute
Jichi medical university
Institute
Department
Personal name
Funding Source
Organization
Jichi medical university department of clinical oncology
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
| 2010 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.spandidos-publications.com/ol/11/6/4049/abstract
Number of participants that the trial has enrolled
Results
https://www.spandidos-publications.com/ol/11/6/4049/abstract
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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 02 | Day |
Last modified on
| 2016 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004940
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