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Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin gene and to be sensitive to the trophic effects of the gastrin in animal models. The hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that will bind gastrin-17, thus preventing the trophic activity of cancer cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | One injection of G17DT followed by up to three booster injections depending on antibody response over 16 week period |
|
| Group 2 | Experimental | Three injections of G17DT with option of one booster after 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G17DT | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse effects | Up to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure serum anti gastrin-17 antibodies to determine immunological response to medication | Up to week 16 |
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Inclusion Criteria:
Histologically verified adenocarcinoma of the colon or rectum
Recurrent/ metastatic disease not amenable to curative surgery and/or radiotherapy
measurable/ evaluable lesions
Life expectancy > 3 months
Karnofsky index > 50% or WHO performance rating of 0-2
Biochemical markers:
Haematological status:
Written consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Queen's Medical Centre | Nottingham | Nottinghamshire | United Kingdom |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |