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Phase 3
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

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.

Inclusion 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

Type of Study:


Study Design:

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


United States: Food and Drug Administration

Study ID:




Start Date:

July 2002

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • Virulizin
  • Immunotherapy
  • Pancreas
  • Pancreatic Cancer
  • clinical trial
  • Pancreatic Neoplasms