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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001180-11 |
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This single arm study will assess progression-free survival, feasibility of use and safety of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line treatment in patients with metastatic colorectal cancer. Patients will receive up to 12 bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-FU | Drug | 3200mg/m2 continuous iv infusions, day 1 every 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | assessed every 8 weeks up to week 102, 3-monthly during follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival; proportion of patients achieving R0 resectability; objective response rate (complete response [CR] and partial response [PR]); proportion of patients completing 12 cycles of chemotherapy. | assessed every 4 weeks up to week 102 and at the end of follow-up period | |
| Proportion of patients with NCI-CTC grade 3-5 adverse events; adverse events, laboratory parameters, ECOG performance status. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | 10117 | Germany | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26335608 | Derived | Stein A, Atanackovic D, Hildebrandt B, Stubs P, Brugger W, Hapke G, Steffens CC, Illerhaus G, Bluemner E, Stohlmacher J, Bokemeyer C. Upfront FOLFOXIRI+bevacizumab followed by fluoropyrimidin and bevacizumab maintenance in patients with molecularly unselected metastatic colorectal cancer. Br J Cancer. 2015 Sep 15;113(6):872-7. doi: 10.1038/bjc.2015.299. Epub 2015 Sep 3. |
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| bevacizumab [Avastin] |
| Drug |
5mg/kg iv infusion, day 1 every 2 weeks |
|
| irinotecan | Drug | 165mg/m2 iv infusion, day 1 every 2 weeks |
|
| leucovorin | Drug | 200mg/m2 iv infusion, day 1 every 2 weeks |
|
| oxaliplatin | Drug | 85mg/m2 iv infusion, day 1 every 2 weeks |
|
| Throughout study, laboratory analyses every 2 weeks, ECOG assessment every 8 weeks |
| Berlin |
| 13347 |
| Germany |
| Bochum | 44791 | Germany |
| Celle | 29221 | Germany |
| Celle | 29223 | Germany |
| Dessau | 06847 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Fulda | 36043 | Germany |
| Hamburg | 20246 | Germany |
| Hamburg | 22087 | Germany |
| Hanover | 30171 | Germany |
| Leer | 26789 | Germany |
| Magdeburg | 39120 | Germany |
| Magdeburg | 39130 | Germany |
| Nuremberg | 90419 | Germany |
| Stade | 21680 | Germany |
| Villingen-Schwenningen | 78052 | Germany |
| 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 |
|---|---|
| D005472 | Fluorouracil |
| D000068258 | Bevacizumab |
| D000077146 | Irinotecan |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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