Clinical Trial 17431

• Overview

  Study 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

  Summary:

  The purpose of this study is to evaluate the safety and effectiveness of glufosfamide, an investigational drug.

  Objective:

  The primary objectives of this study are: 1) To evaluate the efficacy of glufosfamide in patients with metastatic pancreatic adenocarcinoma previously treated with gemcitabine as measured by overall survival compared with Fluorouracil (5-FU) 2) To evaluate the safety of glufosfamide in patients with metastatic pancreatic adenocarcinoma previously treated with gemcitabine compared with Fluorouracil (5-FU)

• Treatments

  Therapies:

  Chemotherapy (NOS)

  Medications:

  5-fluorouracil (); glufosfamide ()

• Inclusion Criteria

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  • 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) for pancreatic cancer (a patient that has received adjuvant gemcitabine and subsequently relapses with 6 months of last gemcitabine dose would be eligible).
  • 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 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

• Exclusion Criteria

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  • 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 (no more than every 2 weeks) 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 (defined as hepatitis mediated elevated LFTs [>2.5 x ULN] in the prior three weeks)
  • Recent (one year) history or symptoms of NYHA Class 2, 3, or 4 cardiovascular disease, 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)
  • Females who are pregnant or breast-feeding
  • Participation in an investigational drug 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

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