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| ID | Type | Description | Link |
|---|---|---|---|
| N° EudraCT : 2008-001195-7 |
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The aim of the study is to determine blood concentration evolution of capecitabine and its active metabolites, in elderly patient 75 years and more.
Blood samples will be taken before 1rst course of chemotherapy of capécitabine for colorectal or breast metastatic cancer.
Pharmacokinetic will be realizes at several times (H0,5, H1, H1,5, H2, H4, H6, H8) and repeated at D14 of the 2d cycle
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Pharmacokinetic of its metabolites. Capecitabine, 1250 mg/m2 twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean value and dispersion of the main plasmatics pharmacokinetics parameters of capécitabine, 5'DFUR, 5-FU and FBAL. | pharmacokinetics of capécitabine | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects evaluation after every course of chemotherapy according to NCI criteria during 6 courses maximum. | Adverse effects | 1 year |
| Objective response comparing lesions' targets according to RECIST criteria, at course n°3 and n°6. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole TUBIANA-MATHIEU, MD | CHU de Limoges, medical oncology department ,02 avenue Martin Luther King 87042 Limoges cedex France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Limoges | Limoges | Province | 87042 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24801171 | Result | Daher Abdi Z, Lavau-Denes S, Premaud A, Urien S, Sauvage FL, Martin J, Leobon S, Marquet P, Tubiana-Mathieu N, Rousseau A. Pharmacokinetics and exposure-effect relationships of capecitabine in elderly patients with breast or colorectal cancer. Cancer Chemother Pharmacol. 2014 Jun;73(6):1285-93. doi: 10.1007/s00280-014-2466-0. Epub 2014 May 7. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| 1 year |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |