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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cancer Advances Inc.
ClinicalTrials.gov Identifier:
NCT00042510
First received: July 31, 2002
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for gastric cancer.


Condition Intervention Phase
Stomach Neoplasms
Esophageal Neoplasms
Biological: Treatment group
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Cancer Advances Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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. [ Time Frame: Through Week 29 ] [ Designated as safety issue: Yes ]

Enrollment: 103
Study Start Date: August 2000
Study Completion Date: July 2004
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Cancer Advances Inc.
ClinicalTrials.gov Identifier: NCT00042510     History of Changes
Other Study ID Numbers: GC4
Study First Received: July 31, 2002
Last Updated: August 27, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 01, 2014