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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
G17DT Immunogen
Sponsored by
Cancer Advances Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, G17DT, gemcitabine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    B

    A

    Arm Description

    Placebo (immunogen vehicle) combined with gemcitabine.

    500 µg G17DT immunogen combined with gemcitabine.

    Outcomes

    Primary Outcome Measures

    Survival

    Secondary Outcome Measures

    Number of Participants with Serious and Non-Serious Adverse Events
    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.

    Full Information

    First Posted
    August 16, 2002
    Last Updated
    April 16, 2014
    Sponsor
    Cancer Advances Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00044031
    Brief Title
    Safety and Efficacy of G17DT Immunogen Combined With Gemcitabine vs. Gemcitabine in the Treatment of Advanced Pancreatic Carcinoma
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2001 (undefined)
    Primary Completion Date
    April 2004 (Actual)
    Study Completion Date
    October 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cancer Advances Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Cancer
    Keywords
    pancreatic cancer, G17DT, gemcitabine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    394 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    B
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo (immunogen vehicle) combined with gemcitabine.
    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    500 µg G17DT immunogen combined with gemcitabine.
    Intervention Type
    Biological
    Intervention Name(s)
    G17DT Immunogen
    Primary Outcome Measure Information:
    Title
    Survival
    Time Frame
    Up to 12 months
    Secondary Outcome Measure Information:
    Title
    Number of Participants with Serious and Non-Serious Adverse Events
    Description
    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.
    Time Frame
    Up to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    R Hawkins, M.D.
    Organizational Affiliation
    Christie Hospital, Manchester
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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