drugset / Trial / NCT00335595
Study of Bevacizumab Alone or Combined With Capecitabine and Oxaliplatin as Support Therapy in Metastatic Colorectal Cancer Patients
Phase 3
Completed
480 enrolled
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Roche Pharma AG · collabSanofi · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the free time to disease progression of combination therapy with capecitabine, oxaliplatin and bevacizumab until disease progression versus capecitabine, oxaliplatin and bevacizumab for 6 cycles followed by bevacizumab until disease progression or a premature drop out of the study.
Timeline
- Start
- 2006-07
- Primary completion
- 2012-06
- Completion
- 2012-06
Publications
- Background Sastre J, Maestro ML, Gomez-Espana A, Rivera F, Valladares M, Massuti B, Benavides M, Gallen M, Marcuello E, Abad A, Arrivi A, Fernandez-Martos C, Gonzalez E, Tabernero JM, Vidaurreta M, Aranda E, Diaz-Rubio E. Circulating tumor cell count is a prognostic factor in metastatic colorectal cancer patients receiving first-line chemotherapy plus bevacizumab: a Spanish Cooperative Group for the Treatment of Digestive Tumors study. Oncologist. 2012;17(7):947-55. doi: 10.1634/theoncologist.2012-0048. Epub 2012 May 29.
- Background Diaz-Rubio E, Gomez-Espana A, Massuti B, Sastre J, Reboredo M, Manzano JL, Rivera F, Safont MJ, Montagut C, Gonzalez E, Benavides M, Marcuello E, Cervantes A, Martinez de Prado P, Fernandez-Martos C, Arrivi A, Bando I, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). Role of Kras status in patients with metastatic colorectal cancer receiving first-line chemotherapy plus bevacizumab: a TTD group cooperative study. PLoS One. 2012;7(10):e47345. doi: 10.1371/journal.pone.0047345. Epub 2012 Oct 12.
- Background Diaz-Rubio E, Pietrantonio F, de Braud F. Continuing single-agent bevacizumab as maintenance therapy after induction XELOX (or FOLFOX) plus bevacizumab in first-line treatment of metastatic colorectal cancer. Oncologist. 2012;17(11):1426-8. doi: 10.1634/theoncologist.2012-0075. Epub 2012 Oct 16.
- Results Diaz-Rubio E, Gomez-Espana A, Massuti B, Sastre J, Abad A, Valladares M, Rivera F, Safont MJ, Martinez de Prado P, Gallen M, Gonzalez E, Marcuello E, Benavides M, Fernandez-Martos C, Losa F, Escudero P, Arrivi A, Cervantes A, Duenas R, Lopez-Ladron A, Lacasta A, Llanos M, Tabernero JM, Anton A, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors. First-line XELOX plus bevacizumab followed by XELOX plus bevacizumab or single-agent bevacizumab as maintenance therapy in patients with metastatic colorectal cancer: the phase III MACRO TTD study. Oncologist. 2012;17(1):15-25. doi: 10.1634/theoncologist.2011-0249. Epub 2012 Jan 10.
- Sastre J, Vidaurreta M, Gomez A, Rivera F, Massuti B, Lopez MR, Abad A, Gallen M, Benavides M, Aranda E, Rubio ED; Spanish Cooperative Group for the Treatment of Digestive Tumors. Prognostic value of the combination of circulating tumor cells plus KRAS in patients with metastatic colorectal cancer treated with chemotherapy plus bevacizumab. Clin Colorectal Cancer. 2013 Dec;12(4):280-6. doi: 10.1016/j.clcc.2013.06.001. Epub 2013 Sep 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | — |
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Oxaliplatin | Small molecule | 130 mg/m2 | — |