Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer
NCT ID: NCT01954992
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
480 participants
INTERVENTIONAL
2014-04-30
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
glufosfamide
Glufosfamide: 4500 mg/m2 IV over 6 hours on Day 1 of each 21-day cycle
Glufosfamide
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.
5-FU
Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week
Fluorouracil
Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Glufosfamide
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.
Fluorouracil
Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eleison Pharmaceuticals LLC.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Edwin Thomas
Role: STUDY_DIRECTOR
Eleison Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Innovative Clinical Research Institute
Whittier, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Kirsten Bettino
Role: primary
Michael Rowland
Role: primary
Carrie Smith
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EP-GF-301
Identifier Type: -
Identifier Source: org_study_id