pancreatic cancer patients with peritoneal metastasis
Conditions
Interventions
intravenous gemcitabine and nab-paclitaxel combined with intraperitoneal paclitaxel on days 1, 8 and 15 every 28 days
Sponsors
Department of Gastroenterology, The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I ; Dose limiting toxicity Phase II; Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I ; Safety Phase II; Response rate, Progression-free survival, Negative conversion rate on peritoneal cytology, Safety | — |
Countries
Japan
Contacts
Public ContactNamianstu Takahara
The University of Tokyo Department of Gastroenterology
Outcome results
None listed