Unique ID issued by UMIN | UMIN000005336 |
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Receipt number | R000006249 |
Scientific Title | A phase I/II study of S-1+Irinotecan+panitumumab as first line treatment to advanced colorectal cancer |
Date of disclosure of the study information | 2011/04/01 |
Last modified on | 2016/10/06 15:30:47 |
A phase I/II study of S-1+Irinotecan+panitumumab as first line treatment to advanced colorectal cancer
PanSIR study
A phase I/II study of S-1+Irinotecan+panitumumab as first line treatment to advanced colorectal cancer
PanSIR study
Japan |
colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
valuation of efficacy and safety profile for combination therapy of S-1+Irinotecan+panitumumab as first line treatment to advanced colorectal cancer.
Safety,Efficacy
Confirmatory
Pragmatic
Phase I,II
phase I: Estimated percentage of dose-limiting toxicity at first course.
phase II: Response rate
frequency of Adverse events
Progression-free survival
Overall survival
Treatment completion rate
Time to treatment failure
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
S-1 80mg/m2 Oral administration day1-15 Irinotacan 150mg/m2 90min div day 1 Panitumumab 9mg/m2 90-30min div day 1
A single course to three weeks.
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients who have diagnosis of colorectal cancer by pathological findings are included.
2) Patients who have unresectable advanced or incipient or recurrent cancer are included.
3) Patients who have cancer with KRAS wild type are included.
4) Patients who have measurable lesions are included.
5) Patients who do not have past histories of chemotherapy.
6) Patients who do not have past histories of treatment by CPT-11 and panitumumab or cetuximab are included.
7) Patients who are over 20 year old and would expect survival over 3 months after registration are included.
8) Patients who are under 2 ECOG performance status are included.
9) Patients who have adequate bone marrow and organ functions are included.
10) UGT1A1 genetic polymorphism
11)Patients who are able to oral administration are included.
12)Patients who have adequate heart function in 28 days before registration are included.
13) Patients who are written informed consent are included.
1) Patients who have allergy for drugs are excluded.
2) Patients who have other malignancies are excluded.
3) Patients who have infections in active are excluded.
4) Patients who have past histories of bowel perforation and / or bowel obstruction in one year before registration are excluded.
5) Patients who have severe diseases are excluded.
6) Patients who have pleural effusion and / or ascites to need treatment are excluded.
7) Patients who have watery diarrhea are excluded.
8) Patients who recieve atazanavir or flucytosin are excluded.
9) Patients who have symptomatic brain metastasis are excluded.
10) Patients who have pregnancy are excluded.
11) Patients who have heavy psycological symptoms are excluded.
12) Patients who receive steroid continuously are excluded.
13) Patients who have past histories of cerebral infarction, cardiac infarction and / or pulmonary infarction are excluded.
14) The patient that a study responsibility physician judged to be inappropriate.
43
1st name | |
Middle name | |
Last name | Ayumu Goto MD. PhD. |
Yokohama City University Hospital
Department of Gastroenterological Surgery
3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
045-787-2800
ayumu16g@yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | Ayumu Goto MD. PhD. |
Yokohama City University Hospital
Clinical Oncology division
3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
045-787-2800
ayumu16g@yokohama-cu.ac.jp
Department of Gastroenterological Surgery
None
Self funding
NO
横浜市立大学附属病院(神奈川県)
神奈川県立がんセンター(神奈川県)
2011 | Year | 04 | Month | 01 | Day |
Unpublished
The dose-limiting toxicities occurred in one patients.
Acute pancreatitis as DLT occurred in ninth patient.
The recommended dose was determined to be 9.0mg/kg of Panitumumab.
One patient had grade 3 diarrhea. None of patients had grade 3 or more severe acneiform. And two grade 3 or 4 hypomagnesemia observed.
Completed
2010 | Year | 11 | Month | 30 | Day |
2011 | Year | 03 | Month | 01 | Day |
2014 | Year | 11 | Month | 30 | Day |
2011 | Year | 03 | Month | 29 | Day |
2016 | Year | 10 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006249
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