18 Years
N/A
Both
Pancreatic Cancer
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:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
LOR/VIR/P03/002
NCT ID:
NCT00040092
Start Date:
July 2002
Completion Date:
Related Keywords:
- Pancreatic Cancer
- Virulizin
- Immunotherapy
- Pancreas
- Pancreatic Cancer
- clinical trial
- Pancreatic Neoplasms
Name | Location |
|---|
