UMIN-CTR Clinical Trial

Basic information
Public title	A phase I/II study of combination therapy with S-1/ CPT-11 plus Panitumumab as second line therapy in metastatic colorectal cancer patients with KRAS wild type
Acronym	A phase I/II study of combination therapy with S-1/ CPT-11 plus Panitumumab as second line therapy in metastatic colorectal cancer patients with KRAS wild type (FUTURE1101)
Scientific Title	A phase I/II study of combination therapy with S-1/ CPT-11 plus Panitumumab as second line therapy in metastatic colorectal cancer patients with KRAS wild type
Scientific Title:Acronym	A phase I/II study of combination therapy with S-1/ CPT-11 plus Panitumumab as second line therapy in metastatic colorectal cancer patients with KRAS wild type (FUTURE1101)
Region	Japan

Condition
Condition	metastatic colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of combination therapy with S-1 and Irinotecan and Panitumumab,in patients with KRAS wild type colorectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	phase1 recommend dose of 1st cycle phase2 response rate
Key secondary outcomes

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;tri-weekly administration 9mg/kg. and CPT-11 is administered as an intravenous infusion at a dose of 150mg/m2(or 125 mg/m2)on day 1 and TS-1 is orally administered on days 1-14 of a 21-day cycle. Administration dose of TS-1 is based BSA : BSA<1.25m2, 40mg twice daily; 1.25-1.5m2, 50mg twice daily; >1.5m2, 60mg twice daily.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Histologically confirmed colorectal cancer 2)Histologically confirmed KRAS wild type on the tumor tissue 3)Unresectable advanced or metastatic colorectal cancer 4) patients with tumor resistant/intolerant to oxaliplatin,fluoropyrimidine 5) ECOG performance status 0,1 6) Age between 20 to 80 years 7) Written informed consent 8) with a good condition of important organs 1.Hb >=9.0g/dl 2.WBC>= 3,000/mm3, <=12,000 mm3 3.neutrophil >= 1,500/mm3 4.platelet >= 100,000/mm3 5.Creatinine < 1.5mg/dl 6.Creatinine clealance: >=50mL/min 7.ALT/AST <= 100IU/l (200 IU/l if the patients has liver metastasis) 8.total bilirubin <= 1.5mg/dl 9)Oral administration of S-1 is possible. 10)Life expectancy of more than 3 months. 11)Presence of measurable lesion 12)Periods from prior treatment have elapsed more than two weeks 13)Prior radiotherapy is not acceptable
Key exclusion criteria	1)Patients with severe complications,(severe cardiovascular disease,severe heart disease,heart failure,liver failure,renal failure or uncontrollable diabetes mellitus) 2)Patients with active infection 3)Patients with severe interstitial pneumonitis or pulmonary fibrosis 4)Patients with active double cancer 5)Patients with paralytic ileus, bowel obstruction 6)Patients with uncontrollable ascites and pleural effusion 7)Patients with diarrhea 8)Patients with the past history of severe allergic reactions 9)Patient with regular use of furucytocin or fenytoin,warfarin 10)psychiatric patients 11)pregnant or nursing patient or with intent to bear baby 12)Patients with the past history of treatment of S-1 and CPT-11 and Panitumumab, Cetuximab 13)Patients with regular use of steroids(oral or intravenous) 14)Patients with brain metastasis 15)Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial
Target sample size	35

Research contact person
Last name of lead principal investigator	1st name Yoichiro Middle name Last name Yoshida
Organization	Fukuoka University School of medicine
Division name	Department of Gastroenterologial Surgery
Zip code	814-0180
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL	0928011011
Email	yy4160@yahoo.co.jp

Public contact
1st name of contact person	1st name Yoichiro Middle name Last name Yoshida
Organization	Fukuoka University School of medicine
Division name	Department of Gastroenterologial Surgery
Zip code	814-0180
Address	7-45-1 Nanakuma, Jonan-ku,Fukuoka
TEL	0928011011
Homepage URL
Email	yy4160@yahoo.co.jp

Sponsor
Institute	Fukuoka Tumor Research(FUTURE)
Institute
Department

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	Fukuoka Univesity
Address	7-45-1, Nanakuma
Tel	0928011011
Email	yy4160@yahoo.co.jp

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 09 Day

Related information
URL releasing protocol	No
Publication of results	Unpublished

Result
URL related to results and publications	No
Number of participants that the trial has enrolled	0
Results	No
Results date posted	2019 Year 05 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	No
Participant flow	No
Adverse events	No
Outcome measures	No
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 02 Month 17 Day
Date of IRB	2011 Year 02 Month 17 Day
Anticipated trial start date	2011 Year 03 Month 01 Day
Last follow-up date	2012 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 03 Month 08 Day
Last modified on	2019 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006192