Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer

Overseen by Vincent J Picozzi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Benaroya Research Institute

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Vincent J Picozzi, MD

Principal Investigator

Virginia mason medical Center

Eligibility Criteria

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0/1.

Serum total bilirubin within normal range for the institution (biliary drainage is allowed for biliary obstruction);

Pathologically proven resectable or borderline resectable pancreatic cancer per current NCCN criteria (http://www.nccn.org/professionals/physician_gls/f_guidelines.asp).

Treatment Details

Interventions

• 5-FU (Anti-metabolites)
• Gemcitabine (Anti-metabolites)
• Leucovorin (Anti-metabolites)
• Nab Paclitaxel (Anti-metabolites)
• Onivyde (Anti-tumor antibiotic)

Participant Groups

Group I: Resectable patients Experimental Treatment 5 Interventions

Gemcitabine and Nab-Paclitaxel Participants received albumin-bound paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle. Followed by nal-IRI (ONIVYDE®) 70 mg/m\^2 followed by leucovorin 400 mg/m\^2 followed by 5FU 2400 mg/m\^2 on days 1, 15 of the 28 day cycle.

Group II: Borderline resectable patients Experimental Treatment 5 Interventions

Gemcitabine and Nab-Paclitaxel Participants received albumin-bound paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle. Followed by nal-IRI (ONIVYDE®) 70 mg/m\^2 followed by leucovorin 400 mg/m\^2 followed by 5FU 2400 mg/m\^2 on days 1, 15 of the 28 day cycle.

Gemcitabine is already approved in Canada, Japan for the following indications:

Approved in Canada as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Japan as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Who Is Running the Clinical Trial?

Benaroya Research Institute

Lead Sponsor

Trials

50

Recruited

12,300+