RECRUITING

Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

Conditions

Metastatic Pancreatic Adenocarcinoma glufosfamide 5-FU

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2014-04

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01954992

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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

Inclusion Criteria

Exclusion 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 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

Contacts and Locations

Study Contact

Edwin Thomas

CONTACT

215 554 3530

clinical@eleison-pharma.com

Principal Investigator

Edwin Thomas

STUDY_DIRECTOR

Eleison Pharmaceuticals

Study Locations (Sites)

Innovative Clinical Research Institute

Whittier, California, 90603

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Gabrail Cancer Center Research

Canton, Ohio, 44718

United States

Collaborators and Investigators

Sponsor: Eleison Pharmaceuticals LLC.

Edwin Thomas, STUDY_DIRECTOR, Eleison Pharmaceuticals

Study Record Dates

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 Registration Dates

Study Start Date2014-04

Study Completion Date2025-12

Study Record Updates

Study Start Date2014-04

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

glufosfamide
5-FU
metastatic pancreatic adenocarcinoma

Additional Relevant MeSH Terms

Metastatic Pancreatic Adenocarcinoma