Study on Low Dose G-FLIP and Mitomycin C for Advanced Pancreatic Cancer

Sponsor: Hirschfeld Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06233877

Provider View

This clinical trial is testing a new combination of low-dose chemotherapy drugs, called G-FLIP, with Mitomycin C to find a safer and more effective treatment for patients with advanced pancreatic cancer.

Patient Parameters

Program Overview

The study is focused on patients with advanced pancreatic cancer that has spread to other parts of the body. It is testing a combination of low-dose chemotherapy drugs (G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin) along with Mitomycin C. The goal is to discover a treatment that is both safer and more effective for this serious condition.

Description

The main goal of this study is to evaluate how safe and effective the combination of G-FLIP and Mitomycin C is for treating advanced pancreatic cancer.

The study is open-label, meaning both the researchers and participants know what treatment is being given. It will include 60 participants who will receive G-FLIP every two weeks and Mitomycin C every four weeks.

Researchers will assess how well the treatment works by looking at how the cancer responds, whether it shrinks, stays the same, or grows. They will also measure how long patients live without the cancer getting worse, overall survival rates, and how many patients survive for at least 12 months.

Safety will be monitored through physical exams, checking symptoms, vital signs, performance status, lab tests, urine tests, and quality of life assessments.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced (Stage IV) pancreatic cancer that has spread.
  • Have not responded to first-line chemotherapy.
  • In good enough health to perform daily activities, with a performance status score between 0 and 2.
  • Expected to live for more than 3 months.
  • Have adequate organ function based on lab tests.
  • Aged 18 or older.
  • Willing to sign an informed consent form.

Exclusion Criteria

  • Have known cancer spread to the brain.
  • Have significant heart problems or other uncontrolled medical conditions.
  • Are pregnant or breastfeeding.

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