Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer

Summary

This phase II trial tests how well gemcitabine, cisplatin and nab-paclitaxel given before surgery (neoadjuvant) works in treating patients with pancreatic cancer that can be removed by surgery (resectable) or that is borderline resectable. The standard treatment for resectable and borderline resectable pancreatic cancer is a combination of surgery and chemotherapy. Neoadjuvant therapy is more feasible and could improve outcomes compared to patients receiving surgery first. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel, an antimicrotubule agent that stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel may have fewer side effects and work better than other forms of paclitaxel. Gemcitabine, cisplatin and nab-paclitaxel may be an effective neoadjuvant treatment option for patients with resectable or borderline resectable pancreatic cancer.

Conditions

• Borderline Resectable Pancreatic Ductal Adenocarcinoma
• Resectable Pancreatic Adenocarcinoma
• Stage I Pancreatic Cancer AJCC v8
• Stage II Pancreatic Cancer AJCC v8
• Stage III Pancreatic Cancer AJCC v8

Interventions

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Gemcitabine

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Nab-paclitaxel

Given IV

PROCEDURE

Pancreatic Surgical Procedure

Undergo surgical resection

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Hussein M Hamad, MD, MPH · Emory University Hospital/Winship Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-06

Primary Completion

2026-12-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations