Status:
COMPLETED
Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
Lead Sponsor:
Corewell Health West
Collaborating Sponsors:
Van Andel Research Institute
Eli Lilly and Company
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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: gemcita...
Detailed Description
This is a Phase II single-armed study evaluating potential benefits of the gemcitabine and etoposide combination in the treatment of patients with locally advanced or metastatic pancreatic cancer. The...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00202800
Start Date
March 1 2002
End Date
January 1 2011
Last Update
June 2 2023
Active Locations (1)
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1
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503