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

This study has been completed.
Sponsor:
Information provided by:
Lorus Therapeutics
ClinicalTrials.gov Identifier:
NCT00040092
First received: June 19, 2002
Last updated: January 4, 2008
Last verified: January 2008
History of Changes
  Purpose

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 Intervention Phase
Pancreatic Cancer
 Drug: Virulizin®
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lorus Therapeutics:

Estimated Enrollment: 400
Study Start Date: July 2002
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00040092     History of Changes
Obsolete Identifiers: NCT00045409
Other Study ID Numbers: LOR/VIR/P03/002
Study First Received: June 19, 2002
Last Updated: January 4, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Lorus Therapeutics:
Virulizin
Immunotherapy
Pancreas
Pancreatic Cancer
clinical trial

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

ClinicalTrials.gov processed this record on May 23, 2013