Study on Nab-Paclitaxel, Cisplatin, Gemcitabine, and Tumor Treatment Fields for Metastatic Pancreatic Cancer

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04605913

Provider View

This clinical trial is testing a new combination of chemotherapy drugs and a treatment called Tumor Treatment Fields (TTF) to see if it can help control metastatic pancreatic cancer. The study aims to find out if this approach can become a new standard treatment for patients with advanced pancreatic cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate a new treatment combination for metastatic pancreatic cancer. It involves using chemotherapy drugs Nab-Paclitaxel, Cisplatin, and Gemcitabine, along with a treatment called Tumor Treatment Fields (TTF). Researchers hope this combination can improve outcomes for patients with stage IV pancreatic cancer. If successful, this approach could change the standard treatment for this type of cancer.

Description

This study is exploring a new treatment strategy for patients with stage IV pancreatic cancer. The treatment combines chemotherapy drugs Nab-Paclitaxel, Cisplatin, and Gemcitabine with Tumor Treatment Fields (TTF), a therapy that uses electric fields to disrupt cancer cell growth. Early trials have shown promising results, with significant tumor response rates. The study will also test a maintenance therapy using TTF and Gemcitabine to see if it can help patients tolerate the treatment better over time. If this initial study is successful, a larger trial may be conducted to confirm the findings.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis.
    • Other metastasis sites are allowed, except for known brain metastasis.
    • Certain types of pancreatic cancer, like squamous or small cell carcinoma, are not eligible.
  • No previous treatment for stage IV metastatic pancreatic cancer.
    • Previous chemotherapy or chemo-radiotherapy is allowed if certain conditions are met.
  • Must be 18 years or older.
  • Meet specific blood and organ function requirements.
  • Have a life expectancy of at least 3 months.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Able to use the Novo TTF-100L (P) system.
  • Have measurable disease on scans.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.

Exclusion Criteria

  • Have received previous treatment for metastatic pancreatic cancer.
  • Have known brain metastasis.
  • Have certain heart conditions or use a pacemaker.
  • Have a high risk of heart problems due to past heart issues.
  • Have other major health conditions that could affect participation.
  • Use medications that could cause heart rhythm problems and cannot be replaced.
  • Have a known allergy to conductive hydrogels.
  • Are pregnant or breastfeeding.

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