Phase II Trial of Gemcitabine and ISIS 2503 in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
OBJECTIVES: I. Determine the 6-month and overall survival rates in patients with locally
advanced or metastatic adenocarcinoma of the pancreas treated with gemcitabine and ISIS
2503. II. Determine the response rate of these patients treated with this regimen. III.
Assess the toxicity of this regimen in this patient population.
OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes on
days 1 and 8 and ISIS 2503 IV continuously on days 1-14. Treatment continues every 21 days
in the absence of disease progression or unacceptable toxicity. Patients are followed every
3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 20-44 patients will be accrued within 10-22 months.
Interventional
Primary Purpose: Treatment
Steven R. Alberts, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000068281
NCT00006467
February 2001
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Medcenter One Health System | Bismarck, North Dakota 58501 |