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

Pancreatic Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044031
• Other study ID #: PC4
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2002
• Last updated: April 16, 2014
• Start date: February 2001
• Est. completion date: October 2007

Study information

• Verified date: April 2014
• Source: Cancer Advances Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: October 2007
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• G17DT Immunogen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Advances Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		Up to 12 months	Yes
Secondary	Number of Participants with Serious and Non-Serious Adverse Events	Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.	Up to 12 months	Yes