Safety and Efficacy of G17DT Immunogen Combined With Gemcitabine vs. Gemcitabine in the Treatment of Advanced Pancreatic Carcinoma

Prospective, Randomized, Controlled, Double-Blind, Multi-National, Multi-Center Study of G17DT Immunogen in Combination With Gemcitabine Versus Placebo in Combination With Gemcitabine in Previously Untreated Subjects With Locally Advanced (Nonresectable Stage II and III), Recurrent Disease Following Primary Resection, or Metastatic (Stage IV) Adenocarcinoma of the Pancreas (Protocol No. PC4)

This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer.

Inclusion criteria:

• Clinical diagnosis of pancreatic adenocarcinoma and unsuitable for pancreatic tumor resection
• Life expectancy of at least 3 months
• Functional status by Karnofsky Index of at least 70

Exclusion criteria:

• Prior treatment with chemotherapy, radiotherapy, or anti-cancer immunotherapy
• Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease
• Immunodeficiency
• Bone marrow transplant within past year
• Brain metastasis