Unique ID issued by UMIN | UMIN000017002 |
---|---|
Receipt number | R000019724 |
Scientific Title | Phase 1 trial of Oxaliplatin/IRInotecan/S-1 (OX-IRIS) as first line chemotherapy for unresectable pancreatic cancer |
Date of disclosure of the study information | 2015/04/01 |
Last modified on | 2022/09/18 17:18:46 |
Phase 1 trial of Oxaliplatin/IRInotecan/S-1 (OX-IRIS) as first line chemotherapy for unresectable pancreatic cancer
HGCSG1403
Phase 1 trial of Oxaliplatin/IRInotecan/S-1 (OX-IRIS) as first line chemotherapy for unresectable pancreatic cancer
HGCSG1403
Japan |
unresectable pancreatic cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
The aim of this study is to determine the recommended dose for the phase II study based on the observed dose-limiting toxicities.
Safety
Exploratory
Pragmatic
Phase I
frequency of DLT (Dose Limiting Toxicity) , determination of MTD (Maximum Tolerated Dose)
the frequency of side effect, response rate, progression-free survival, overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
oxaliplatin, irinotecan, S-1
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Pathologically diagnosed invasive ductal carcinoma
2) Unresectable locally advanced, metastatic, or recurrent disease
3) No prior chemotherapy or radiotherapy for pancreatic cancer
4) Aged 20 to 75 years old
5) ECOG PS of 0 or 1
6) Adequate organ functions
7) Sufficient oral intake
8) Written informed consent
1) Grade 2 or greater peripheral neuropathy
2) Having UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 gene
3) Moderate ascites
4)Intestinal pneumonitis or pulmonary fibrosis
5) Uncontrollable diarrhea
6) Serious complications (organ failure, uncontrolled diabetes mellitus, active infection, ulcer, ileus, mental disorders, or central nervous system disorders)
8) Active double cancer
9) Pregnancy
10)Inappropriate for this study judged by the attending physician
18
1st name | Yoshito |
Middle name | |
Last name | Komatsu |
Hokkaido University Hospital
Cancer Center
060-8638
North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
011-716-1161
ykomatsu@med.hokudai.ac.jp
1st name | Yasuyuki |
Middle name | |
Last name | Kawamoto |
Hokkaido University Hospital
Gastroenterology and Hepatology
060-8638
North 15, West 7, Kita-ku, Sapporo,
011-716-1161
y-kawamoto0716@hotmail.co.jp
Hokkaido University Hospital Cancer Center
Hokkaido Gastrointestinal Caner Study Group (HGCSG)
Other
Institutional Review Board of Hokkaido University Hospital
Kita 14 Nishi 5, Kita-ku, Sapporo
011-706-7636
crjimu@huhp.hokudai.ac.jp
NO
2015 | Year | 04 | Month | 01 | Day |
Not applicable
Published
https://doi.org/10.1002/onco.13838
13
Two of five enrolled in level 0 (L-OHP: 85 mg/m2, IRI: 100 mg/m2, S-1: 80 mg/m2) had DLT. One of six in level -1 (L-OHP: 65 mg/m2, IRI: 100 mg/m2, S-1: 80 mg/m2) had DLT.
At level 0, 100% of cases had anemia and fatigue, 80% anorexia, diarrhea, peripheral sensory neuropathy, 60% platelet count decrease.
At level -1, 100% had anemia, 75% nausea and fatigue, 63% anorexia.
2019 | Year | 10 | Month | 06 | Day |
2021 | Year | 06 | Month | 21 | Day |
The patients' backgrounds were median age 62; male /female, 9/4; the primary tumor sites head /body and tail, 8/5; ECOG PS 0/1, 7/6; UR-LA /UR-M, 4/9.
Two of five enrolled in level 0 (L-OHP: 85 mg/m2, IRI: 100 mg/m2, S-1: 80 mg/m2) had DLT. One of six in level -1 (L-OHP: 65 mg/m2, IRI: 100 mg/m2, S-1: 80 mg/m2) had DLT.
At level 0, 100% of cases had anemia and fatigue, 80% anorexia, diarrhea, peripheral sensory neuropathy, 60% platelet count decrease.
At level -1, 100% had anemia, 75% nausea and fatigue, 63% anorexia.
Response rate was 10% and disease control rate was 70% in ten cases with evaluable lesion. Median PFS was 4.1 months (95%C.I.; 0.0-8.6 months). Median OS was 13.7 months (95%C.I.; 5.9-21.5 months).
Completed
2015 | Year | 10 | Month | 26 | Day |
2015 | Year | 10 | Month | 23 | Day |
2015 | Year | 11 | Month | 02 | Day |
2018 | Year | 08 | Month | 25 | Day |
2018 | Year | 09 | Month | 30 | Day |
2018 | Year | 10 | Month | 31 | Day |
2015 | Year | 04 | Month | 01 | Day |
2022 | Year | 09 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019724
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