NCT03703063

Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer

Alternating Neoadjuvant Gemcitabine-Nab-Paclitaxel and Nanoliposomal Irinotecan (Nal-IRI) With 5-Fluorouracil and Folinic Acid (Leucovorin) Regimens in Resectable and Borderline Resectable Pancreatic Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Benaroya Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	Administered by intravenous infusion over 30 minutes.
DRUG	nab paclitaxel	Administered by intravenous infusion over 30-40 minutes.
DRUG	Onivyde	Administered by intravenous infusion over 90 minutes.
DRUG	Leucovorin	Administered by intravenous infusion over 30 minutes.
DRUG	5-fu	Administered by intravenous infusion over 46 hours.

Timeline

• Start date: 2018-09-17
• Primary completion: 2021-09-17
• Completion: 2022-09-17
• First posted: 2018-10-11
• Last updated: 2021-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study