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

Completed · Phase 2

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT00202800

Run by

Corewell Health West

People needed

40

Starts

2002-03-01

Expected to finish

2011-01-01

Last updated by the study team

2023-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Grand Rapids Clinical Oncology Program — Grand Rapids, Michigan, United States

Full record on ClinicalTrials.gov

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