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 |
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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
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
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
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
