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The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen is given combined with Oxaliplatin (OxPt).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | Capecitabine in week 1,2,4,5,7 and 8 Cetuximab in week 3 to 9 Oxaliplatin in week 7 |
|
| B | Other | Capecitabine in weeks 1,2,4,5,7, and 8 Cetuximab in weeks 1,8 and 9 Oxaliplatin in week 7 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood samples | Other | Draw blood samples in week 1 (day 1 and day 5), in week 4 (day 1 and day 5) and in week 7 (day 1 and day 5). day 1: pre dose, 30,60,90,120,150,180,240,300 and 360min day 5: pre dose, 30,60,90,120min |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of Cetuximab on metabolic activation of Capecitabine | Curve fitting of drug and metabolite concentrations will be performed. For pharmacokinetic modelling of CCB and metabolites, a non-compartment model for extravascular input will be used. For calculation of AUC and AUMC the linear trapezoid rule will be applied for the ascending part of the concentraion-time curve and the log-linear trapezoidal rule for the descending part of the concentration-time curve. | 9 weeks |
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Inclusion Criteria selected:
Exclusion Criteria selected:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PMU Salzburg | Salzburg | State of Salzburg | 5020 | Austria | ||
| AKH Wien |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 19, 2017 | |
| Reset | Nov 1, 2017 | |
| Release | Dec 6, 2017 | |
| Unrelease | Yes | |
| Release | Jan 8, 2019 | |
| Unrelease | Jan 21, 2019 | |
| Release | Jan 21, 2019 | |
| Reset | Apr 19, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 19, 2017 | Nov 1, 2017 | |||
| Dec 6, 2017 |
| 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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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Vienna |
| State of Vienna |
| 1090 |
| Austria |
| Kaiser Franz Josef Spital | Vienna | State of Vienna | 1100 | Austria |
| Yes |
| Jan 8, 2019 | Jan 21, 2019 |
| Jan 21, 2019 | Apr 19, 2019 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |