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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00044031
First Posted: August 20, 2002
Last Update Posted: April 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cancer Advances Inc.
  Purpose
This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer.

Condition Intervention Phase
Pancreatic Cancer Biological: G17DT Immunogen Phase 3

Cancer Advances Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Cancer Advances Inc.:

Primary Outcome Measures:
  • Survival [ Time Frame: Up to 12 months ]

Secondary Outcome Measures:
  • Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: 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.


Enrollment: 394
Study Start Date: February 2001
Study Completion Date: October 2007
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: B
Placebo (immunogen vehicle) combined with gemcitabine.
Experimental: A
500 µg G17DT immunogen combined with gemcitabine.
Biological: G17DT Immunogen

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044031


Sponsors and Collaborators
Cancer Advances Inc.
Investigators
Principal Investigator: R Hawkins, M.D. Christie Hospital, Manchester
  More Information

Responsible Party: Cancer Advances Inc.
ClinicalTrials.gov Identifier: NCT00044031     History of Changes
Other Study ID Numbers: PC4
First Submitted: August 16, 2002
First Posted: August 20, 2002
Last Update Posted: April 17, 2014
Last Verified: April 2014

Keywords provided by Cancer Advances Inc.:
pancreatic cancer
G17DT
gemcitabine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Gastrins
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists