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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Health Hospitals
• Collaborators: Battle Creek Health System; Eli Lilly and Company; Hackley Hospital; Mecosta County General Hospital; Mercy Health System; Metropolitan Hospital, Michigan; Munson Medical Center; Saint Mary's Health Care; Saint Mary's Health Network; Van Andel Research Institute
• Treatments: Etoposide; Etoposide phosphate; Gemcitabine

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.