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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.

Tracking Information
First Submitted Date  ICMJE August 16, 2002
First Posted Date  ICMJE August 20, 2002
Last Update Posted Date April 17, 2014
Study Start Date  ICMJE February 2001
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
Survival [ Time Frame: Up to 12 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of G17DT Immunogen Combined With Gemcitabine vs. Gemcitabine in the Treatment of Advanced Pancreatic Carcinoma
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Biological: G17DT Immunogen
Study Arms  ICMJE
  • Placebo Comparator: B
    Placebo (immunogen vehicle) combined with gemcitabine.
  • Experimental: A
    500 µg G17DT immunogen combined with gemcitabine.
    Intervention: Biological: G17DT Immunogen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2014)
394
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00044031
Other Study ID Numbers  ICMJE PC4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cancer Advances Inc.
Study Sponsor  ICMJE Cancer Advances Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: R Hawkins, M.D. Christie Hospital, Manchester
PRS Account Cancer Advances Inc.
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP