Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer

VARI-002-1

Pancreatic cancer is a devastating disease. Previous research shows a correlation between a specific oncogene change (ras-mutation) and enhanced sensitivity to two chemotherapy drugs combined: gemcitabine and etoposide. This Phase II trial will evaluate this drug combination for locally advanced and metastatic pancreatic cancer.

2002-03-01

2007-09-01

2011-01-01

Completed

Early phase I

40

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-06-02