A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Intervention: imexon in combination with gemcitabine; imexon placebo + gemcitabine
Intervention description: 875 mg/m^2 imexon IV + 1000 mg/m^2 gemcitabine IV; imexon placebo IV + 1000 mg/m^2 gemcitabine IV
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pancreatic cancer; metastatic; chemotherapy naive

Summary:

      The purpose of this study is to determine if imexon in combination with gemcitabine could
      improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer
      that has spread to other organs such as the liver or lungs. The study will also look at the
      safety of the combination as compared to gemcitabine alone. Participants in the study will be
      randomly assigned to either treatment and neither the participant or their doctors will know
      which treatment they will be receiving.
    

Eligibility criteria:

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