A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Fluorouracil (5-FU) in Patients With Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine
Eleison Pharmaceuticals LLC.
Summary
The study is designed to assess whether glufosfamide provides additional survival benefit as compared to bolus 5-FU in patients with metastatic pancreatic cancer who have already progressed or failed therapy on a gemcitabine based first line regimen.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * At least 18 years of age * Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided) * Metastatic pancreatic cancer * Disease progression during or after treatment with gemcitabine (alone or in combination with other agents; at regular, not radiosensitizing, doses) * Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion) * Recovered from reversible toxicities of prior therapy * ECOG performance status 0-1 * All women of childbearing potential and all men must agree to use effect…
Interventions
- DrugGlufosfamide
Glufosfamide: 4500 mg/m2 IV over 6 hours (¼ dose over 30 minutes, ¾ dose over remaining 5.5 hours) on Day 1 of each 21-day cycle.
- DrugFluorouracil
Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week
Locations (3)
- Innovative Clinical Research InstituteWhittier, California
- Moffitt Cancer CenterTampa, Florida
- Gabrail Cancer Center ResearchCanton, Ohio