Actively Recruiting
A Randomized Study Comparing Glufosfamide and Fluorouracil (5-FU) in Patients With Metastatic Pancreatic Cancer Previously Treated With Gemcitabine
Led by Eleison Pharmaceuticals LLC. ยท Updated on 2024-12-31
480
Participants Needed
3
Research Sites
661 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether glufosfamide can improve survival compared to bolus 5-fluorouracil (5-FU) in adults with metastatic pancreatic cancer who have already undergone treatment with a gemcitabine-based therapy but whose disease has progressed. This Phase 3 study focuses on patients with pancreatic adenocarcinoma confirmed by biopsy or cytology and aims to assess overall survival over approximately 3 to 6 months. Participants are randomly assigned to receive either glufosfamide or fluorouracil. Glufosfamide is given intravenously at 4500 mg/m2 over 6 hours on Day 1 of each 21-day cycle, while fluorouracil is administered intravenously at 600 mg/m2 over 30 minutes once weekly. The study evaluates the safety and effectiveness of these two drug regimens in this patient population. Throughout the study, participants undergo regular assessments including tumor measurements by RECIST criteria, clinical evaluations, and laboratory tests to monitor health and treatment effects. Patients must have recovered from previous therapy side effects and maintain good performance status. Safety monitoring includes checking for infections, blood counts, liver and kidney function, and cardiovascular health. The study requires participants to use effective contraception during treatment and for six months after. Total participation duration depends on treatment cycles and disease progression.
CONDITIONS
Official Title
Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Pancreatic adenocarcinoma confirmed by histology or cytology
- Metastatic pancreatic cancer
- Disease progression during or after gemcitabine treatment
- Measurable or nonmeasurable disease by RECIST criteria
- Recovered from prior therapy toxicities
- ECOG performance status 0-1
- Use of effective contraception from study entry through 6 months post-treatment
- Ability to understand study and provide informed consent
You will not qualify if you...
- More than one prior systemic therapy regimen for metastatic pancreatic cancer
- Systemic or local antitumor therapy within 14 days before study start
- Insulin-dependent diabetes mellitus
- Symptomatic brain metastases
- Active infection needing antibiotics
- Known HIV positive or active hepatitis B or C
- Recent (within 1 year) significant cardiovascular disease
- Other active malignancies within past year except treated non-melanoma skin or in situ cancer
- Major surgery within 3 weeks without full recovery
- Significant lab abnormalities including low hemoglobin, low ANC, low platelets, high bilirubin, elevated liver enzymes, low phosphorus or potassium, high serum creatinine, or low creatinine clearance
- Pregnancy or breastfeeding
- Participation in another investigational study within 14 days
- Medical conditions or medications increasing risk of kidney problems
- Contraindication or refusal for multiple CT scans
- Inability or unwillingness to comply with study protocol
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Innovative Clinical Research Institute
Whittier, California, United States, 90603
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Actively Recruiting
Research Team
E
Edwin Thomas
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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