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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cancer Advances Inc.
ClinicalTrials.gov Identifier:
NCT00044031
First received: August 16, 2002
Last updated: April 16, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044031

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

No publications provided

Responsible Party: Cancer Advances Inc.
ClinicalTrials.gov Identifier: NCT00044031     History of Changes
Other Study ID Numbers: PC4
Study First Received: August 16, 2002
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 09, 2014