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oxaliplatin
CONCEPT: Comparison of Oxaliplatin vs Conventional Methods With Calcium/Magnesium in First-Line Metastatic Colorectal Cancer
Ensayo de Sanofi en Cancer colorrectal.
Más ensayos de: Cáncer colorrectal.
- Fase
- Fase 4
- Estado
- Interrumpido
- Participantes
- 180
- Centros
- 1
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en feb 2005.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Unplanned interim analysis by DSMB indicated possible reduced response rate with the addition of Ca/Mg in pooled population. Further analysis pending.».
Qué mide
Time to treatment failure (TTF) for the conventional oxaliplatin (CO) schedule in comparison with the intermittent oxaliplatin (IO) schedule (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary rationale for this study is to develop an optimized schedule of administration of FOLFOX + bevacizumab that maximizes the efficacy and safety of this regimen when administered to patients with advanced colorectal cancer. The hypothesis is that the use of an intermittent oxaliplatin (IO) schedule of FOLFOX/bevacizumab will allow these patients to continue on treatment for a longer period of time by reducing the proportion of patients who discontinue therapy early because of treatment-related toxicities and thus increasing the possibility of a longer time to progression. The primary objective is: * To test the hypothesis that an intermittent oxaliplatin (IO) schedule of FOLFOX/bevacizumab will allow patients to remain on therapy for a longer period of time compared to a conventional "treat-to-failure" schedule, by reducing the proportion of patients who discontinue therapy for treatment-related toxicities. The secondary objectives are: * To evaluate the impact of calcium/magnesium infusions on the incidence and severity of neurotoxicity in subjects receiving either the IO or conventional FOLFOX/bevacizumab treatment schedules as first-line treatment for metastatic colorectal cancer. * To evaluate the safety and efficacy of the IO versus the conventional schedule + calcium and magnesium infusions, as part of oxaliplatin-based first-line therapy for metastatic colorectal cancer.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00129870), actualizada en feb 2009.