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

Pancreatic Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00006467
Study type Interventional
Source Alliance for Clinical Trials in Oncology
Contact
Status Completed
Phase Phase 2
Start date February 2001
Completion date January 2004
View Details
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