An Open Label Phase 2 Trial to Evaluate the Safety, Tolerability, and Efficacy of Low Dose G-FLIP in Combination With Mitomycin C in Patients With Stage IV Pancreatic Cancer Who Have Failed First-Line Treatment
Hirschfeld Oncology
Summary
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 pat…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugG-GLIP plus Mitomycin C
G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin plus Mitomycin C
Location
- Hirscheld OncologyBrooklyn, New York