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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06423326
Phase
PHASE2
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Cisplatin — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Gemcitabine — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Nab-paclitaxel — DRUG
    Given IV
  • Pancreatic Surgical Procedure — PROCEDURE
    Undergo surgical resection

Study Details

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.

Key Dates

Start date
Aug 6, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nab-paclitaxel, cisplatin, gemcitabine)
    Patients receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 15 of each cycle. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease, partial or complete response undergo surgical resection per standard of care. Additionally, patients undergo biopsy on study and undergo blood sample collection and CT or MRI at pre-study and on study.

Primary Outcome Measure

Clinical Response Rate to Neoadjuvant Chemotherapy [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Kathleen M. Coleman
[email protected]
Hussein Hamad, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Emory University Hospital/Winship Cancer Institute· Atlanta, GA

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