RecruitingPhase 2NCT06423326

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

A Single-Arm Phase II Clinical Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Pancreatic Ductal Adenocarcinoma


Sponsor

Emory University

Enrollment

36 participants

Start Date

Aug 6, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three chemotherapy drugs (gemcitabine, cisplatin, and nab-paclitaxel) given before surgery to shrink pancreatic cancer in people whose tumors may or may not be removable. The goal is to see whether pre-surgery chemo improves outcomes. **You may be eligible if...** - You have been diagnosed with pancreatic cancer that is either removable or borderline removable (based on how close it is to nearby blood vessels) - You are over 18 years old - You are in good overall health (ECOG 0–1) - Your blood counts, liver, and kidney function are acceptable - You do not have cancer spread to other parts of the body **You may NOT be eligible if...** - You have significant nerve damage (neuropathy) affecting daily activities - You have had a heart attack, stroke, or serious heart problem within the past 6 months - You have uncontrolled diabetes or a serious active infection - You are pregnant or breastfeeding - You have another serious medical condition that could interfere with treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGCisplatin

Given IV

PROCEDUREComputed Tomography

Undergo CT

DRUGGemcitabine

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGNab-paclitaxel

Given IV

PROCEDUREPancreatic Surgical Procedure

Undergo surgical resection


Locations(1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

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NCT06423326


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