UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

Progression-free survival

Key secondary outcomes

Response rate
Overall survival
Disease control rate
Adverse events
Biomarkers on clinical examination data

Study type

Interventional

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

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

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

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

Email

hmishima@aichi-med-u.ac.jp

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

Email

miya@ecrin.or.jp

Institute

Epidemiological and Clinical research Information Network (ECRIN)

Institute

Department

Personal name

Organization

Epidemiological and Clinical research Information Network (ECRIN)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

04

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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