Using alternative neoadjuvant gemcitabine-nab-paclitaxel and nal-IRI with 5-Fluorouracil (5FU) and folinic acid (Leucovorin) regimens of localized cancer, we hope to ensure exposure of the cancer to a broader array of potentially active agents. Also, potentially improves patient tolerance and minimizes significant drug toxicity that could impair delivery of all treatment elements. Furthermore, it may enable prediction of superior to inferior treatment outcomes at an earlier point in the disease progress.
This research study is a Phase Ib clinical trial. It will assess the Safety, tolerability, and feasibility of gemcitabine-nab paclitaxel alternating with nal-IRI/5FU/leucovorin (NAPOLI) in de novo resectable and borderline resectable pancreatic cancer. Subjects must have a newly diagnosed resectable or borderline resectable pancreatic ductal cancer and meet all inclusion/exclusion criteria. Treatment consists of 4 week treatment cycles. Nab-paclitaxel and gemcitabine will be administered on days 1,8, and 15 with NAPOLI will be administered on days 1 and 15.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Administered by intravenous infusion over 30 minutes.
Administered by intravenous infusion over 30-40 minutes.
Administered by intravenous infusion over 90 minutes.
Virginia mason medical Center
Seattle, Washington, United States
RECRUITINGTreatment safety as assessed by CTCAE v4.03
Toxicities are evaluated according to CTCAE v4.03
Time frame: An average of 1 year
Overall survival
OS is defined as the time between the date of enrollment and the date of death (whatever the cause).
Time frame: 5 years
Progression free survival (PFS)
PFS is defined as the time between the date of enrollment and the date of the first radiological and/or pathological progression. Progression is assessed by investigator according to RECIST v1.1 criteria.
Time frame: 5 years
Response rate
Response rate will be assessed per RECIST v1.1 criteria and CA19-9 over the entire treatment period.
Time frame: An average of 1 year
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Administered by intravenous infusion over 30 minutes.
Administered by intravenous infusion over 46 hours.