UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005218
Receipt number R000006192
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
Date of disclosure of the study information 2011/03/09
Last modified on 2019/05/23 16:02:10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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

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 or person

Institute

Fukuoka Tumor Research(FUTURE)

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006192


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name