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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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Patients with metastatic colorectal cancer will be treated with chemotherapy according to investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients KRAS status will be tested. After having fulfilled these 18 weeks of induction treatment, patients who has responded (complete response/partial response versus stable disease) will be randomized to maintenance treatment. Patients with KRAS WT will be randomized to either bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS mutation will be randomized to either bevacizumab, or metronomic capecitabine. Translational research is performed, with purpose to find predictive factors in blood and tumor tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bevacizumab and erlotinib (KRAS WT) | Active Comparator |
| |
| bevacizumab (KRAS WT) | Active Comparator |
| |
| bevacizumab (KRAS mutated) | Active Comparator |
| |
| low dose capecitabine (KRAS mutated) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab, erlotinib | Drug | bevacizumab 7.5 mg/kg body weight every third week, erlotinib 150 mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression free survival (PFS) compared to treatment with only bevacizumab. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To explore the activity of bevacizumab and low dose metronomic capecitabine in patients with KRAS mutated tumors. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Odense | Denmark | ||||
| County Hospital Ryhov |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26483047 | Derived | Hagman H, Frodin JE, Berglund A, Sundberg J, Vestermark LW, Albertsson M, Fernebro E, Johnsson A. A randomized study of KRAS-guided maintenance therapy with bevacizumab, erlotinib or metronomic capecitabine after first-line induction treatment of metastatic colorectal cancer: the Nordic ACT2 trial. Ann Oncol. 2016 Jan;27(1):140-7. doi: 10.1093/annonc/mdv490. Epub 2015 Oct 19. |
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| bevacizumab | Drug | bevacizumab 7.5 mg/kg body weight every third week |
|
|
| bevacizumab | Drug | bevacizumab 7.5 mg/kg body weight every third week. |
|
|
| low dose capecitabine | Drug | capecitabine 500 mg twice daily |
|
|
| Jönköping |
| Sweden |
| County Hospital | Kalmar | Sweden |
| Central Hospital | Karlstad | Sweden |
| University Hospital | Linköping | Sweden |
| Skåne University Hospital-Lund | Lund | 221 85 | Sweden |
| Karolinska University Hospital | Stockholm | Sweden |
| Sundsvall Hospital | Sundsvall | Sweden |
| Norrland University Hospital | Umeå | Sweden |
| Akademiska Hospital | Uppsala | Sweden |
| Central Hospital | Vaxjo | Sweden |
| Central Hospital | Västerås | Sweden |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069347 | Erlotinib Hydrochloride |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| 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 |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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