Unique ID issued by UMIN | UMIN000017538 |
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Receipt number | R000020312 |
Scientific Title | Phase II study of pegfilgrastim as support to metastatic pancreatic cancer patients receiving FOLFIRINOX |
Date of disclosure of the study information | 2015/05/15 |
Last modified on | 2015/05/13 12:06:21 |
Phase II study of pegfilgrastim as support to metastatic pancreatic cancer patients receiving FOLFIRINOX
Phase II study of pegfilgrastim as support to metastatic pancreatic cancer patients receiving FOLFIRINOX
Phase II study of pegfilgrastim as support to metastatic pancreatic cancer patients receiving FOLFIRINOX
Phase II study of pegfilgrastim as support to metastatic pancreatic cancer patients receiving FOLFIRINOX
Japan |
Metastatic pancreatic cancer
Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Adult |
Malignancy
NO
To evaluate the safety and effectiveness of pegfilgrastim as primary prophyraxis in patients with metastatic pancreatic cancer receiving FOLFIRINOX
Safety,Efficacy
Exploratory
Pragmatic
Phase II
incidence of febrile neutropenia during the first 3 cycles of treatment
Overall Survival, Progression Free Survival, Response Rate, Relative Dose Intensity, Adverse events, Severe adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Pegfilgrastim
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1)Histologically or cytologically proved pancreatic adenocarcinoma or adenosquamous carcinoma
2)ECOG Performance Status 0-1
3)Metastatic pancreatic cancer with measurable lesion according to RECIST ver.1.1
4)Meets the following criteria within 7days before enrollment
hemoglobin: >9 g/dL
absolute neutrophil: >2000/mm3
platelet count: >100,000/mm3
AST and ALT: <2.5 X ULN
total bilirubin: <ULN
serum creatinine: <1.2mg/dL
5)written informed consent to participate in this study
1)Prior radiotherapy or chemotherapy
2)Grade 2 or greater peripheral neuropathy
3)Blood transfusion, administration of blood products, or hematopoietic (e.g., G-CSF) support within 7 days before enrollment
4)UGT genetic polymorphisms of homozygous UGT1A1*6 or UGT1A1*28 or heterozygous UGT1A1*6 and *28
5)confirm the presence of ascites or peritoneal metastasis by imaging
6)Intestinal pneumonitis or pulmonary fibrosis
7)severe diarrhea within 3 days before enrollment
8)Clinically significant heart disease
9)Active infection (except HBV+,HCV+)
10)Poor glycemic control diabetes mellitus
11)Serious complications (organ failure, or active peptic ulcer etc)
12)Severe mental disorder, or central nervous system disorders
13)Serious drug allergy
14)Active double cancer
15)Brain or meningeal metastasis
16)Pregnancy
17)Treatment with atazanavir sulfate
18)Inappropriate for this study judged by the investigator
35
1st name | |
Middle name | |
Last name | Hideki Ueno |
National Cancer Center Hospital
Department of Hepatobiliary Pancreatic Oncology
5-1-1 Tsukiji Chuo-ku Tokyo
03-3542-2511
hiueno@ncc.go.jp
1st name | |
Middle name | |
Last name | Mitsuhito Sasaki |
National Cancer Center Hospital
Department of Hepatobiliary Pancreatic Oncology
5-1-1 Tsukiji Chuo-ku Tokyo
03-3542-2511
mitsasak@ncc.go.jp
National Cancer Center Hospital
Ministry of Education, Culture, Sports, Science and Technology
NO
2015 | Year | 05 | Month | 15 | Day |
Unpublished
Open public recruiting
2015 | Year | 04 | Month | 27 | Day |
2015 | Year | 05 | Month | 01 | Day |
2015 | Year | 05 | Month | 13 | Day |
2015 | Year | 05 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020312
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