Glufosfamide Versus 5-FU In Second Line Metastatic Pancreatic Cancer

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-09-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-12-30
First Submitted that Met QC Criteria 2013-09-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-12-31
First Posted (ACTUAL) 2013-10-07	Results First Posted N/A	Last Verified 2024-12

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: glufosfamide Glufosfamide: 4500 mg/m2 IV over 6 hours on Day 1 of each 21-day cycle	DRUG: 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.
ACTIVE_COMPARATOR: 5-FU Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week	DRUG: Fluorouracil Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: glufosfamide

Glufosfamide: 4500 mg/m2 IV over 6 hours on Day 1 of each 21-day cycle

DRUG: 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.

ACTIVE_COMPARATOR: 5-FU

Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week

DRUG: Fluorouracil

Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival	Time from Randomization to death from any cause	Approximately 3-6 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Learn

Resources

Patients

Caregivers

Clinical Trial Record