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Docetaxel + Oxaliplatin

Docetaxel and Oxaliplatin in Gastric Cancer

Ensayo de Sanofi en Stomach Neoplasms (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

275

previstos

Centros

12

Fin del objetivo primario

abr 2010

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2006.

Qué mide

Time to Progression (every 8 weeks up to a maximum of 36 months) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm. The optimal dose was administered in the Part II study. Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population. Primary objective: * To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease (part II). Secondary objectives: * To establish the safety profile. * To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO) criteria * To assess the Overall Survival (OS)

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Ficha completa en ClinicalTrials.gov (NCT00382720), actualizada en dic 2012.