Clinical Trial Evaluating Low Dose G-FLIP Plus Mitomycin C for Stage IV Pancreatic Cancer

Sponsor: Hirschfeld Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06233877

Patient View

This open-label study evaluates the safety, tolerability, and efficacy of G-FLIP plus Mitomycin C in 60 subjects with Stage IV pancreatic cancer. Participants must have failed first-line chemotherapy, have an ECOG status of 0-2, and adequate organ function. Efficacy is assessed through response rates and survival metrics, while safety includes physical exams and quality of life assessments.

Patient Parameters

Program Overview

The study focuses on advanced metastatic pancreatic cancer, testing a combination of low-dose anti-cancer drugs (G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin) with the addition of Mitomycin C. The aim is to find a safer and more effective therapy for this devastating disease.

Description

Objective: Evaluate the safety, tolerability, and efficacy of G-FLIP combined with Mitomycin C for advanced pancreatic cancer.

Design: Open-label study with 60 evaluable subjects. Treatments: G-FLIP administered every 2 weeks, with Mitomycin administered every 4 weeks.

Efficacy Assessments: Based on response criteria (Complete Response, Partial Response, Stable Disease, Progressive Disease), Response Rate, Progression-Free-Survival, Overall Survival, and 12-Month Survival Rate.

Safety Assessments: Include physical exams, symptom evaluation, vital signs, ECOG performance status, clinical pathology, urinalysis, and Quality of Life assessments.

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed metastatic (Stage IV) pancreatic adenocarcinoma.

    • Failed first-line chemotherapy.
    • ECOG performance status of 0-2.
    • Expected survival of more than 3 months.
    • Adequate organ function as indicated by lab values.
    • Age 18 or older.
    • Signed informed consent.

Exclusion Criteria

  • • Known brain metastases.

    • Significant cardiovascular or other uncontrolled diseases.
    • Pregnant or breastfeeding women

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