This 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)