A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer

Inclusion Criteria

• •1. Patients with histologically or cytologically confirmed, chemotherapy naive, metastatic pancreatic adenocarcinoma (Stage IV). This does not include patients with only locally advanced pancreatic cancer.
• •2. At least one unidimensional measurable metastatic lesion by contrast enhanced CT scan (or MRI in patients ineligible for contrast enhanced CT) that are outside any prior radiation port.
• •3. Age at least 18 years.
• •4. ECOG performance status 0 or 1.
• •5. No prior chemotherapy or radiation therapy.
• •6. Projected life expectancy at least 2 months.
• •7. If female, neither pregnant nor lactating.
• •8. If of child bearing potential must agree to, and be able to use adequate contraception.
• •9. Concomitant disease: No respiratory insufficiency requiring oxygen therapy; no angina at rest; no myocardial infarction in previous 3 months; no life threatening ventricular arrhythmias. No uncompensated CHF or NY Heart Association class 3 or 4 cardiac disease.
• •10. No other concurrent active malignancy.
• •11. No infection requiring parenteral antibiotic therapy at the start of protocol treatment.
• •12. Laboratory values within the following criteria:
• •Hgb greater than or equal to 9 gm/dL WBC greater than or equal 3,500/mm\^3 ANC greater than or equal 1,500/mm\^3 Platelet count greater than or equal 100,000/mm\^3 Creatinine greater than or equal 2.0 Bilirubin less than or equal to 2.0 Hepatic enzymes (AST, ALT) less than or equal 3 times upper limit of normal (ULN)
• •13. G6PD level greater than or equal lower limit of normal (LLN).
• •14. Able to render informed consent and follow protocol requirements.