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Safety and Efficacy of G17DT Immunogen in the Treatment of Gastric and Gastroesophageal Cancer

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: NCT00042510
Recruitment Status : Completed
First Posted : August 1, 2002
Last Update Posted : August 28, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Esophageal Neoplasms Biological: Treatment group Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2000
Primary Completion Date : February 2003
Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment Group
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.
Biological: Treatment group


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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): NCT00042510


Sponsors and Collaborators
Cancer Advances Inc.
Investigators
Principal Investigator: Jaffer A Ajani, M.D. U.S. studies
Principal Investigator: Vladimir Moiseyenko, M.D., Ph.D Non U.S. studies
More Information

Responsible Party: Cancer Advances Inc.
ClinicalTrials.gov Identifier: NCT00042510     History of Changes
Other Study ID Numbers: GC4
First Posted: August 1, 2002    Key Record Dates
Last Update Posted: August 28, 2014
Last Verified: August 2014

Keywords provided by Cancer Advances Inc.:
Gastroesophageal cancer
Gastric cancer

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases