UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007658 |
|---|---|
| Receipt number | R000009025 |
| Scientific Title | Multicenter Phase II Study of Panitumumab and Irinotecan with or without Fluoropyrimidines in patients with KRAS Wild-type Metastatic Colorectal Cancer (PACIFIC) |
| Date of disclosure of the study information | 2012/04/04 |
| Last modified on | 2018/09/20 08:19:02 |
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Basic information
Public title
Multicenter Phase II Study of Panitumumab and Irinotecan with or without Fluoropyrimidines in patients with KRAS Wild-type Metastatic Colorectal Cancer (PACIFIC)
Acronym
PACIFIC Study
Scientific Title
Multicenter Phase II Study of Panitumumab and Irinotecan with or without Fluoropyrimidines in patients with KRAS Wild-type Metastatic Colorectal Cancer (PACIFIC)
Scientific Title:Acronym
PACIFIC Study
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Hematology and clinical oncology | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of panitumumab + irinotecan with or without fluoropyrimidines as 2nd line therapy in patients with KRAS wild-type metastatic colorectal cancer. And, to investigate the relationship of early response of panitumumab and clinical examination data.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Response rate
Overall survival
Disease control rate
Adverse events
Biomarkers on clinical examination data
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Irinotecan 150 mg/m2/biweekly div
l-LV 200mg/m2/biweekly div
5-FU/bolus 400mg/m2/biweekly div (bolus)
5-FU/infusional 2,400mg/m2/biweekly div Panitumumab 6mg/kg/biweekly div
or
S-1 80mg/m2/day p.o. day 1-7
Irinotecan 150mg/m2 day 1
Panitumumab 6mg/kg/biweekly div
Interventions/Control_2
Irinotecan 150mg/m2/ biweekly div Panitumumab 6mg/kg/biweekly div
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)Histologically confirmed colorectal cancer
2)KRAS wild type
3)Measurable lesions in RECIST V1.1
4)One prior first line chemotherapy consisting of fluoropyrimidine and oxaliplatin with or without bevacizumab.
5)Age, 20 years old and above
6)ECOG performance status of 0-2
7)Sufficient organ functions
a)WBC=>3000/mm3
b)Neutrophil=>1500/mm3
c)Platelet count=>75000/mm3
d)Hemoglobin=>8.0g/dL
e)Total bilirubin<=2*ULN
f)AST ALT<= 100 lU/L(Liver Met; AST, ALT<=199lU/L)
g)Creatinine<=1.5*ULN
h)<S-1> Ccr=>50mL/min
i)Urine protein<=1+
8)Life expectancy of at least 8 week
9)Written informed consent
Key exclusion criteria
1) Brain metastasis (symptomatic)
2) Diarrhea
3) Intestinal paralysis or obstruction
4) With infectious diseases or febrile condition
5) With severe pulmonary diseases (interstitial pneumonitis, pulmonary fibrosis)
6) With severe diseases ( DM, heart failure, renal failure, liver dysfunction)
7) Pregnant or possibly pregnant, and nursing women
8) Carcinomatous menigitis, history of mental or cerebrovascular disorder
9) With grade 3 peripheral neuropathy
10) Administration of contraindicative medicines
11) History of administration of antagonisms to EGF signal
12) Other conditions not suitable for this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Mishima |
Organization
Aichi Medical University
Division name
Cancer Center
Zip code
Address
1-1, Yazakokarimata Nagakute, Aichi
TEL
0561-62-3311
hmishima@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Miyashita |
Organization
Epidemiological and Clinical research Information Network (ECRIN)
Division name
Data Center
Zip code
Address
1-7-9 hanenishi okazaki aichi
TEL
0564-64-7300
Homepage URL
miya@ecrin.or.jp
Sponsor or person
Institute
Epidemiological and Clinical research Information Network (ECRIN)
Institute
Department
Personal name
Funding Source
Organization
Epidemiological and Clinical research Information Network (ECRIN)
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 04 | 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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 05 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 04 | Day |
Last modified on
| 2018 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009025
