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The purpose of this study is to determine the rate of progression free survival of patients with inoperable cholangiocarcinoma 6 months after enrollment in the study. The patients are treated with combination chemotherapy supplemented by biological agents panitumumab or bevacizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination chemotherapy + panitumumab | Experimental |
| |
| Combination chemotherapy + bevacizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | 1,000 mg/m2 on day 1 of a 2 weeks cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| The fraction of patients alive and without progression at 6 months | 6 months from enrollment date |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate before cross-over | 6 months after enrollment or earlier in case of progression | |
| Overall survival | 6 months | |
| Progression free survival and response rate after cross-over |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Jakobsen, MD, DMSc | Department of Oncology, Vejle Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Vejle Hospital | Vejle | DK-7100 | Denmark |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D000077544 | Panitumumab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Oxaliplatin | Drug | 60 mg/m2 on day 1 of a 2 weeks cycle |
|
| Capecitabine | Drug | 1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle |
|
| Panitumumab | Drug | 6 mg/kg on day 1 of a 2 weeks cycle |
|
| Bevacizumab | Drug | 10 mg/kg on day 1 of a 2 weeks cycle |
|
| 6 months |
| D009369 | Neoplasms |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |