Phase 3 Study Comparing Glufosfamide and Fluorouracil 5-FU for Treatment of Metastatic Pancreatic Cancer After Gemcitabine Therapy

What this Trial Is About

Researchers are evaluating whether glufosfamide offers additional survival benefits compared to bolus fluorouracil 5-FU in patients with metastatic pancreatic adenocarcinoma who have already experienced disease progression after treatment with a gemcitabine-based first-line therapy. This randomized Phase 3 trial is sponsored by Eleison Pharmaceuticals LLC and focuses on patients with advanced pancreatic cancer who have measurable or nonmeasurable disease and have recovered from prior treatment toxicities. Participants are randomly assigned to receive either glufosfamide or fluorouracil. Glufosfamide is given intravenously at a dose of 4500 mgm2 over 6 hours on Day 1 of each 21-day cycle, while fluorouracil is administered intravenously at 600 mgm2 over 30 minutes once weekly. These treatments continue throughout the study period as patients are monitored for response and safety. During the trial, participants will undergo regular assessments including imaging scans to measure disease status according to RECIST criteria, laboratory tests, and clinical evaluations to monitor side effects and overall health. The main outcome measured is overall survival, observed over approximately 3 to 6 months. The study also monitors participants performance status and treatment adherence, with follow-up continuing until study completion or patient withdrawal.

Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer