Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Gemcitabine/Etoposide, Ras-mutation
Eligibility Criteria
Inclusion Criteria: Patients with locally advanced or metastatic adenocarcinoma of the pancreas. Patients may have received prior immunotherapy, radiation therapy, or surgery, but must be > 4 weeks out from therapy and have recovered fully from its effects. Patients must be 18 years of age or older. Patients must have unidimensional measurements obtainable using RECIST criteria (see Protocol Attachment E). Karnofsky Performance Scale must be 50 or better (see Protocol Attachment A). Patient must have the following hematologic and chemical parameters: ANC > 1,000 cells/mm3 Hemoglobin > 9 gm/dL Platelets > 100,000 cells/mm3 SGOT/SGPT < 3 x normal, unless there is known liver involvement. Then they must be < 5x normal. Bilirubin < 2.0 mg/dL Creatinine < 2.0 mg/dL Female within childbearing years must use an accepted contraceptive method. Patient must have a life expectancy of at least eight (8) weeks. A signed informed consent must be obtained prior to study entry. Exclusion Criteria: Previous chemotherapy with the exception of 5FU given as part of an adjuvant regimen. Pregnant or nursing females. Concurrent radiation therapy. Patients with other active neoplasms are ineligible. Patients with serious active infections or other underlying medical conditions, which would impair their ability to receive the treatment as prescribed. Disease Diagnostic Criteria and Staging: Patients must have a histologic or cytologic diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas using standard pathologic criteria. Staging will be according to AJCC criteria.
Sites / Locations
- Grand Rapids Clinical Oncology Program