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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00044031

Enrollment

394

Registered

2002-08-20

Start date

2001-02-28

Completion date

2007-10-31

Last updated

2014-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer, G17DT, gemcitabine

Brief summary

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

Interventions

BIOLOGICALG17DT Immunogen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Survival	Up to 12 months

Secondary

Measure	Time frame	Description
Number of Participants with Serious and Non-Serious Adverse Events	Up to 12 months	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026