Spots Global Cancer Trial Database for Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas

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Trial Identification

Brief Title: Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas

Official Title: Phase II Trial of Gemcitabine and ISIS 2503 in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma

Study ID: NCT00006467

Conditions

Pancreatic Cancer

Interventions

ISIS 2503

gemcitabine hydrochloride

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with ISIS 2503 in treating patients who have advanced or metastatic cancer of the pancreas.

Detailed Description: 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.