A Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00040092
Recruitment Status : Completed
First Posted : June 20, 2002
Last Update Posted : January 7, 2008
Information provided by:
Aptose Biosciences Inc.

Brief Summary:
Virulizin is an immunotherapy drug preparation that is thought to stimulate the patient's immune system, which in turn may slow the growth of tumors. It is presented in vials as a sterile preparation for IM injection. The purpose of the trial is to investigate if Virulizin in combination with gemcitabine provides better efficacy than gemcitabine alone (with placebo) against pancreatic cancer.Virulizin® efficacy will continue to be assessed if chemotherapy is changed to 5-Fluorouracil.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Virulizin® Phase 3

Detailed Description:

A Phase III, Double-blind, Multicenter, Randomized Study in Chemonaive Patients with Locally Advanced or Metastatic Pancreatic Cancer to Compare a Combination Therapy of Virulizin® plus Gemcitabine versus Placebo plus Gemcitabine; Optional Secondline Therapy may Include Continuation of Virulizin® or Placebo, Alone or in Combination with 5-Fluorouracil.

Patients who have not received any prior chemotherapy will be randomized to receive Gemcitabine plus Virulizin® versus Gemcitabine plus placebo in a double blind fashion. On disease progression patients may be switched to 5-Fluorouracil and continue to receive Virulizin® or placebo. Patients may continue Virulizin® alone, if clinically indicated when 5-Fluorouracil is discontinued.

Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : July 2002
Actual Primary Completion Date : July 2005

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Patients with advanced (unresectable or metastatic) pancreatic adenocarcinoma (TNM stages II, III or IV)
  • No previous systemic chemotherapy(unless given as a radiosensitizer).
  • ECOG Performance Status 0-2
  • Life expectancy equal to or greater than 12 weeks
  • Adequate laboratory and organ functions
  • Stabilizable pain (stable analgesic intake)
  • No radiotherapy during 4 weeks prior to trial entry
  • No evidence of ascites, pleural effusion or third space fluid accumulation
  • Not currently using, and have not used in 4 weeks prior to entering trial, systemic steroids or hormonal therapy

Publications: Identifier: NCT00040092     History of Changes
Obsolete Identifiers: NCT00045409
Other Study ID Numbers: LOR/VIR/P03/002
First Posted: June 20, 2002    Key Record Dates
Last Update Posted: January 7, 2008
Last Verified: January 2008

Keywords provided by Aptose Biosciences Inc.:
Pancreatic Cancer
clinical trial

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases