MedTrace Logo

Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer

NCT03703063 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-01-27

No results posted yet for this study

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.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

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.

Sponsors & Collaborators

  • Benaroya Research Institute

    lead OTHER

Principal Investigators

  • Vincent J Picozzi, MD · Virginia mason medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2021-09-17
Completion
2022-09-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03703063 on ClinicalTrials.gov