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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01936 | Registry Identifier | NCI Clinical Trials Reporting Office |
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| Name | Class |
|---|---|
| Sirtex Medical | INDUSTRY |
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This trial is testing the safety of combining the oral chemotherapy drug capecitabine with radio-labeled microspheres injected directly into the liver.
Patients with adequate liver function and performance status in whom liver-directed therapy and capecitabine would be appropriate are eligible for this clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (SIRT and capecitabine) | Experimental | Patients receive capecitabine PO twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo SIRT on day 2 and may undergo a second course of SIRT on day 58. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIRT | Radiation | Undergo SIRT |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety, toxicity, and recommended phase II dose (RPTD) of capecitabine when administered concurrently with SIR-Spheres in patients with advanced cancer. | ongoing |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven J. Cohen, M.D. | Fox Chase Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D037761 | Sirtuins |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D056545 | Group III Histone Deacetylases |
| D006655 | Histone Deacetylases |
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
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| capecitabine | Drug | Given PO |
|
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| D008107 |
| Liver Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D036002 | ADP Ribose Transferases |
| D010430 | Pentosyltransferases |
| D016695 | Glycosyltransferases |
| D014166 | Transferases |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |