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

Hirschfeld Oncology

Status and phase

Not yet enrolling

Phase 2

Conditions

Pancreatic Cancer

Treatments

Drug: G-GLIP plus Mitomycin C

Study type

Interventional

Funder types

Other

Identifiers

NCT06233877

G-FLIP-M Pancreatic

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.