Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer
Trial Parameters
Brief Summary
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.
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 Commi