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

Inclusion criteria

• Patients with histologically or cytologically confirmed, chemotherapy naive, metastatic pancreatic adenocarcinoma (Stage IV). This does not include patients with only locally advanced pancreatic cancer.
• 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.
• Age at least 18 years.
• ECOG performance status 0 or 1.
• No prior chemotherapy or radiation therapy.
• Projected life expectancy at least 2 months.
• If female, neither pregnant nor lactating.
• If of child bearing potential must agree to, and be able to use adequate contraception.
• 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.
• No other concurrent active malignancy.
• No infection requiring parenteral antibiotic therapy at the start of protocol treatment.
• 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)

• G6PD level greater than or equal lower limit of normal (LLN).
• Able to render informed consent and follow protocol requirements.

Exclusion criteria

• Patients with locally advanced, non-metastatic pancreas cancer (Stage III or below).
• Age less than 18 years.
• ECOG performance status 2 or greater.
• Prior anticancer drug therapy for metastatic disease.
• Ascites.
• Prior abdominal or thoracic surgery < 4 weeks before the start of therapy.
• Current or prior brain metastases. Brain MRI or CT required pre-registration only if the patient has CNS symptoms indicating a need for evaluation.
• Life expectancy projected less than 2 months.
• Pregnancy or lactation.
• Unable or unwilling to utilize medically acceptable contraception if of childbearing potential.
• Laboratory parameters outside of specified ranges, (see above).
• Infection requiring parenteral antibiotics.
• NY Heart Association stage 3 or 4 heart disease.
• Unable to render informed consent.
• Failure to meet any of the eligibility criteria as outlined above.