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This study was designed to investigate the antibody response generated by a 500µg dose of G17DT in patients with gastric cancer.
Another study, GC2, initiated prior to the start of this study investigated the appropriate dose and dosing schedule for G17DT in patients with Stage I-III gastric cancer. The highest dose tested in the GC2 study was 250µg. This dose was well tolerated but was not considered sufficiently immunogenic. Since tolerability had not constrained dosing up to 250µg, the GC5 study was designed to investigate a 500µg dose administered as a regimen of 0, 2, and 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G17DT | Experimental | Treatment with 500µg/ 0.4mL dose of G17DT administered by intramuscular injection at 0, 2, and 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G17DT | Biological |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Antibody Levels | Gastrin-17 antibodies are produced as a result of treatment with G17DT and the proportion of patients producing gastrin-17 antibodies was considered to be an appropriate measure of the immunogenicity of the dosing schedule under study. | Through Week 12 |
| Injection Site Reaction | A physical examination for the presence of an abscess at the injection site was performed on each patient to assess tolerability to treatment at every posttreatment visit from Week 0 to Week 12. | Up to Week 12 |
| Change in Subject's World Health Organization Performance Status | The subject's WHO performance status was evaluated at each visit up to Week 12 to assess changes in subject's ability complete normal daily activities. | Through Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Vital status was monitored throughout the study. Patients were followed up to their death or the study completion date, 18 June 2001. | From date of randomization up to Week 24 or until death |
| Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
Haemoglobin (Hb) < 10g/dL White blood cell count (WBC) < 4.0 x 10^9/L Platelets < 100 x 10^9/L
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| Name | Affiliation | Role |
|---|---|---|
| Robert Stuart, MB ChB | Glasgow Royal Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glasgow Royal Infirmary | Glasgow | G31 2 ER | United Kingdom |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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All adverse events reported during the study.
| Through week 12 |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |