Safety and Efficacy of G17DT Immunogen in the Treatment of Gastric and Gastroesophageal Cancer
Phase 2
Completed
- Conditions
- Stomach NeoplasmsEsophageal Neoplasms
- Interventions
- Biological: Treatment group
- Registration Number
- NCT00042510
- Lead Sponsor
- Cancer Advances Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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