Back to resultsSafety and Efficacy of G17DT Immunogen in the Treatment of Gastric and Gastroesophageal Cancer
Primary Purpose
Stomach Neoplasms, Esophageal Neoplasms
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Treatment group
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring Gastroesophageal cancer, Gastric cancer
Eligibility Criteria
Inclusion criteria: Clinical diagnosis with gastric or gastroesophageal cancer Karnofsky performance status score of at least 70 Life expectancy of at least 3 months Exclusion criteria: Prior treatment with chemotherapy or anticancer immunotherapy Bone marrow transplant within past year Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease Central nervous system metastases Immunodeficiency Hypercalcemia
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
500µg G17DT administered on Weeks 1, 5 and 9 and an additional treatment at Week 25. Cisplatin was administered every 4 weeks on the first day of each treatment cycle as a 1 to 3 hour intravenous infusion at a dose of 100mg/m^2. 5-FU was administered every 4 weeks during the first 5 days of each cycle as a continuous intravenous infusion at a dose of 1,000 mg/m^2/d.
Outcomes
Primary Outcome Measures
To evaluate the effects of G17DT in combination with cisplatin and 5-FU chemotherapy on tumor response assessed by radiographic means.
Secondary Outcome Measures
To evaluate the clinical efficacy of G17DT in combination with cisplatin and 5-FU chemotherapy as measured by time to disease progression, best overall response and survival.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00042510
Brief Title
Safety and Efficacy of G17DT Immunogen in the Treatment of Gastric and Gastroesophageal Cancer
Official Title
Open-Label,Multicenter Study of G17DT Immunogen in Combination w/ Cisplatin and 5-FU in Subjects w/ Metastatic or Locally Recurrent Gastric or Gastroesophageal Cancer Previously Untreated With Chemotherapy.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
July 2004 (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 gastric cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Esophageal Neoplasms
Keywords
Gastroesophageal cancer, Gastric cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
500µg G17DT administered on Weeks 1, 5 and 9 and an additional treatment at Week 25. Cisplatin was administered every 4 weeks on the first day of each treatment cycle as a 1 to 3 hour intravenous infusion at a dose of 100mg/m^2. 5-FU was administered every 4 weeks during the first 5 days of each cycle as a continuous intravenous infusion at a dose of 1,000 mg/m^2/d.
Intervention Type
Biological
Intervention Name(s)
Treatment group
Primary Outcome Measure Information:
Title
To evaluate the effects of G17DT in combination with cisplatin and 5-FU chemotherapy on tumor response assessed by radiographic means.
Time Frame
Through Week 29
Secondary Outcome Measure Information:
Title
To evaluate the clinical efficacy of G17DT in combination with cisplatin and 5-FU chemotherapy as measured by time to disease progression, best overall response and survival.
Time Frame
Through Week 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Clinical diagnosis with gastric or gastroesophageal cancer
Karnofsky performance status score of at least 70
Life expectancy of at least 3 months
Exclusion criteria:
Prior treatment with chemotherapy or anticancer immunotherapy
Bone marrow transplant within past year
Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease
Central nervous system metastases
Immunodeficiency
Hypercalcemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaffer A Ajani, M.D.
Organizational Affiliation
U.S. studies
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vladimir Moiseyenko, M.D., Ph.D
Organizational Affiliation
Non U.S. studies
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of G17DT Immunogen in the Treatment of Gastric and Gastroesophageal Cancer
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