Study on Personalized Chemotherapy for Metastatic Pancreatic Cancer

Sponsor: University Health Network, Toronto

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04469556

Provider View

This clinical trial is testing two standard chemotherapy treatments for patients with metastatic pancreatic cancer to see which works better. The study also includes advanced lab tests to understand how different patients respond to these treatments.

Patient Parameters

Program Overview

This study is exploring two common chemotherapy treatments, modified folfirinox (mFFX) and gemcitabine/nab-paclitaxel (GA), for patients with metastatic pancreatic cancer that hasn't been treated yet. Researchers will also use lab tests to look at the cancer's genetic makeup and other factors to see how they affect treatment response. The goal is to find out which treatment works better and to develop personalized treatment plans based on individual patient characteristics.

Description

The trial involves two chemotherapy treatments that are commonly used for advanced pancreatic cancer: mFFX and GA. Researchers want to see if one treatment helps patients live longer without the cancer getting worse. They will also study the cancer's genetic profile and other markers to understand why some patients respond better to treatment than others. This study will include about 150 patients who will be randomly assigned to receive one of the two treatments. By using patient-derived models, the study aims to advance personalized medicine approaches for pancreatic cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with metastatic pancreatic cancer that hasn't been treated yet.
  • Cancer type must be adenocarcinoma or similar variants.
  • Can have a second type of cancer if it doesn't interfere with this study.
  • Age 18 or older.
  • Must have a tumor that can be biopsied.
  • Suitable for treatment with either mFFX or GA chemotherapy.
  • Good overall health with a performance status score of 0 or 1.
  • Expected to live more than 90 days.
  • Women must not be pregnant and agree to use birth control during the study.
  • Normal organ and bone marrow function within 14 days before starting the study.

Exclusion Criteria

  • Have received previous treatment for pancreatic cancer.
  • Have a type of pancreatic cancer other than ductal adenocarcinoma, except for adenosquamous.
  • Cannot safely undergo a tumor biopsy.
  • Have known brain metastases.
  • Have uncontrolled health issues like infections or heart problems.
  • Have a genetic mutation in BRCA, PALB2, or similar genes.
  • Are pregnant or breastfeeding.
  • Have substance abuse issues that could affect study participation.

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