Stomach Neoplasms Clinical Trial
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.
Verified date | August 2014 |
Source | Cancer Advances Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for gastric cancer.
Status | Completed |
Enrollment | 103 |
Est. completion date | July 2004 |
Est. primary completion date | February 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cancer Advances Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the effects of G17DT in combination with cisplatin and 5-FU chemotherapy on tumor response assessed by radiographic means. | Through Week 29 | Yes | |
Secondary | 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 | Yes |
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