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

Cancer Advances

Status and phase: Completed; Phase 3

Conditions: Pancreatic Cancer

Treatments: Biological: G17DT Immunogen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00044031

PC4

Details and patient eligibility

About

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

Enrollment: 394 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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394 participants in 2 patient groups, including a placebo group

B

Placebo Comparator group

Description:

Placebo (immunogen vehicle) combined with gemcitabine.

A

Experimental group

Description:

500 µg G17DT immunogen combined with gemcitabine.

Treatment:

Biological: G17DT Immunogen