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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00042510

Enrollment

103

Registered

2002-08-01

Start date

2000-08-31

Completion date

2004-07-31

Last updated

2014-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Neoplasms, Stomach Neoplasms

Keywords

Gastroesophageal cancer, Gastric cancer

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.

Interventions

BIOLOGICALTreatment group

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To evaluate the effects of G17DT in combination with cisplatin and 5-FU chemotherapy on tumor response assessed by radiographic means.	Through Week 29

Secondary

Measure	Time frame
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.	Through Week 29

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026