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

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.
 
ClinicalTrials.gov Identifier: NCT00044031
Recruitment Status : Completed
First Posted : August 20, 2002
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Cancer Advances Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: G17DT Immunogen Phase 3

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 394 participants
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)
Study Start Date : February 2001
Actual Primary Completion Date : April 2004
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Gemcitabine

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: B
Placebo (immunogen vehicle) combined with gemcitabine.
Experimental: A
500 µg G17DT immunogen combined with gemcitabine.
 Biological: G17DT Immunogen


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

Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Principal Investigator: R Hawkins, M.D. Christie Hospital, Manchester
More Information
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Responsible Party: Cancer Advances Inc.
ClinicalTrials.gov Identifier: NCT00044031    
Other Study ID Numbers: PC4
First Posted: August 20, 2002    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014
Keywords provided by Cancer Advances Inc.:
pancreatic cancer
G17DT
gemcitabine
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases