Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

Launched by ELEISON PHARMACEUTICALS LLC. · Sep 27, 2013

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called glufosfamide to see if it helps people with metastatic pancreatic cancer live longer compared to a standard treatment called 5-FU. This trial is for patients who have already tried a treatment called gemcitabine but their cancer has continued to grow or has come back. The researchers want to find out if glufosfamide can give these patients more time and better outcomes.

To join the trial, participants need to be at least 18 years old and have a confirmed diagnosis of metastatic pancreatic adenocarcinoma. They should have experienced cancer progression after gemcitabine treatment and be well enough to participate, as indicated by a performance status score. Patients will undergo regular check-ups and may receive glufosfamide or 5-FU to compare the effects. It's important for potential participants to understand the risks and benefits of the study, and they will need to sign a consent form before joining. This study is currently recruiting participants and aims to provide valuable information on treating pancreatic cancer.

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Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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