Unique ID issued by UMIN | UMIN000024148 |
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Receipt number | R000027806 |
Scientific Title | A phase I/II study of intravenous gemcitabine and nab-paclitaxel combined with intraperitoneal paclitaxel in pancreatic cancer patients with peritoneal metastasis |
Date of disclosure of the study information | 2017/01/01 |
Last modified on | 2023/01/04 08:28:48 |
A phase I/II study of intravenous gemcitabine and nab-paclitaxel combined with intraperitoneal paclitaxel in pancreatic cancer patients with peritoneal metastasis
Phase I/II study of GnP + IP PTX
A phase I/II study of intravenous gemcitabine and nab-paclitaxel combined with intraperitoneal paclitaxel in pancreatic cancer patients with peritoneal metastasis
Phase I/II study of GnP + IP PTX
Japan |
pancreatic cancer patients with peritoneal metastasis
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the efficacy and safety of intravenous gemcitabine and nab-paclitaxel combined with intraperitoneal paclitaxel in pancreatic cancer patients with peritoneal metastasis.
Safety,Efficacy
Exploratory
Phase I,II
Phase I ; Dose limiting toxicity
Phase II; Overall survival
Phase I ; Safety
Phase II; Response rate, Progression-free survival, Negative conversion rate on peritoneal cytology, Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
intravenous gemcitabine and nab-paclitaxel combined with intraperitoneal paclitaxel on days 1, 8 and 15 every 28 days
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) histologically or cytologically proven pancreatic adenocarcinoma
2) No previous antitumorcancer treatment other than surgery and adjuvant chemotherapy
3) peritoneal metastasis confirmed by diagnostic imaging, staging laparoscopy or laparotomy within 14 days before registration
4) adequate organ functions(according to the laboratory data which was taken within 7 days before registration)
5) Eastern Cooperative Oncology Group performance status 0-1
6) oral intake
7) written informed consent
1) contraindication for gemcitabine, nab-paclitaxel or paclitaxel
2) other active concomitant malignancies
3) allergy to iodine or gadolinium contrast agent
4) Blood transfusion or usege of G-CSF within 7 days before enrollment
5) past or current severe heart disease, liver cirrhosis, active GI ulcers or obstruction
6) severe complications such as interstitial pneumonitis, pulmonary fibrosis
7) uncontrollable diabetes mellitus
8) grade 3/4 of sensory neuropathy
9) active infection rather than HBV/HCV
11) pregnant or nursing women
12) judged to be unfit to participate in this study by investigators
53
1st name | Yousuke |
Middle name | |
Last name | Nakai |
The University of Tokyo
Department of Gastroenterology
113-8655
7-3-1, Hongo, Bunkyo-ku, Tokyo
03-+3815-5411
isayama-tky@umin.ac.jp
1st name | Namianstu |
Middle name | |
Last name | Takahara |
The University of Tokyo
Department of Gastroenterology
113-8655
7-3-1, Hongo, Bunkyo-ku, Tokyo
03-3815-5411
naminatsu-takahara@umin.ac.jp
Department of Gastroenterology, The University of Tokyo
The University of Tokyo
Self funding
The University of Tokyo, Clinical Research Review Board
7-3-1, Hongo, Bunkyo-ku, Tokyo
03-5841-0818
ethics@m.u-tokyo.ac.jp
NO
2017 | Year | 01 | Month | 01 | Day |
Unpublished
No longer recruiting
2016 | Year | 08 | Month | 26 | Day |
2016 | Year | 10 | Month | 30 | Day |
2017 | Year | 01 | Month | 01 | Day |
2024 | Year | 06 | Month | 30 | Day |
2016 | Year | 09 | Month | 24 | Day |
2023 | Year | 01 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027806
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