Inclusion Criteria

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In order to be included in the study, patients must have/be:

  1. Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas test4

  2. Documented metastatic disease; disease status may be measurable or non-measurable as defined by RECIST v1.1 guidelines

  3. Documented disease progression after prior gemcitabine or gemcitabine containing therapy, in locally advanced or metastatic setting.  Examples of permitted therapies include, but are not limited to:

  • Single agent gemcitabine

  • Any one gemcitabine-based regimen, with or without maintenance gemcitabine

  • Single agent gemcitabine to which a platinum agent, a fluoropyrimidine, or erlotinib was subsequently added

  • Gemcitabine administered in the adjuvant setting if disease recurrence occurred within 6 months of completing the adjuvant therapy

  1. Karnofsky Performance Status (KPS) > 70

  2. Adequate bone marrow reserves as evidenced by:

  • ANC > 1,500 cells/µl without the use of hematopoietic growth factors; and

  • Platelet count > 100,000 cells/µl; and

  • Hemoglobin > 9 g/dL (blood transfusions are permitted for patients with hemoglobin levels below 9 g/dL)

  1. Adequate hepatic function as evidenced by:

  • Serum total bilirubin within normal range for the institution (biliary drainage is allowed for biliary obstruction)

  • Albumin levels > 3.0 g/dL

  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN is acceptable if liver metastases are present)

  1. Adequate renal function as evidenced by a serum creatinine ≤ 1.5 x ULN

  2. Normal ECG or ECG without any clinically significant findings

  3. Recovered from the effects of any prior surgery, radiotherapy or other anti-neoplastic therapy

  4. At least 18 years of age

  5. Able to understand and sign an informed consent (or have a legal representative who is able to do so)

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