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Glufosfamide vs. 5-FU for Metastatic Pancreatic Cancer

This study is looking at whether glufosfamide can help people with metastatic pancreatic adenocarcinoma (a type of pancreatic cancer that has spread) live longer compared to a standard chemotherapy called fluorouracil (5-FU). You might be able to join if you are at least 18 years old, have metastatic pancreatic cancer confirmed by a doctor, and your cancer has gotten worse during or after treatment with gemcitabine. The main goal is to see if glufosfamide improves overall survival, which will be measured over approximately 3 to 6 months. The current status of this study is unclear.

Study design
This study is designed to compare glufosfamide to fluorouracil (5-FU) in patients with metastatic pancreatic cancer. It aims to enroll 480 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Overall survival will be measured at approximately 3-6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01954992

Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

Recruiting
PHASE3Ages 18+InterventionalTreatment
Eleison Pharmaceuticals LLC.
~480 participants
Updated 2024-12-31 on ClinicalTrials.gov
What's tested:GlufosfamideFluorouracil

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival
Measured over Approximately 3-6 months

Conditions

Metastatic Pancreatic Adenocarcinoma

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NCT01954992

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Gabrail Cancer Center Research

    Canton, Ohiostudy coordinator listed

    Recruiting

  • Innovative Clinical Research Institute

    Whittier, Californiastudy coordinator listed

    Recruiting

  • Moffitt Cancer Center

    Tampa, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Edwin Thomas · STUDY_DIRECTOR · Eleison Pharmaceuticals

Who to contact

Edwin Thomas
[email protected]
215 554 3530
Email the study team

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Eligibility criteria

Inclusion

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 effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose of chemotherapy
Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee

Exclusion

More than one prior systemic therapy regimen for metastatic pancreatic cancer (radiosensitizing doses of 5-FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen)
Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 14 days prior to Cycle 1 Day 1
Insulin-dependent diabetes mellitus (patients with type 2 diabetes controlled with oral glucose lowering agents and the occasional use of insulin are permitted in the study)
Symptomatic brain metastases (baseline CT scan is not required in asymptomatic patients)
Active clinically significant infection requiring antibiotics
Known HIV positive or active hepatitis B or C
Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure
No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year
Major surgery within 3 weeks of the start of study treatment, without complete recovery
Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis)
Hemoglobin \<9 g/dL (may receive transfusion or erythropoietin to maintain)
ANC \<1500/μL
Platelet count \<100,000/μL
Total bilirubin \> 1.5×ULN
AST/ALT \> 2.5-fold above ULN (\>5-fold above ULN if liver metastases)
Phosphorus \< LLN
Potassium \< LLN
Serum creatinine \> 2 mg/dL
Creatinine clearance \< 60 mL/min (calculated by Cockcroft-Gault formula)
Females who are pregnant or breast-feeding
Participation in an investigational drug or device study within 14 days of the first day of dosing on this study
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study
Any medical history, concurrent disease or concomitant medication which could reasonably predispose the patient to renal insufficiency while on study treatment
Contraindication or unwillingness to undergo multiple CT scans
Unwillingness or inability to comply with the study protocol for any other reason

What this trial measures

  • Overall SurvivalApproximately 3-6 months

    Time from Randomization to death from any cause