Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

Arms (2)

1. type

   EXPERIMENTAL

   label

   A

   interventionNames

   1. Drug: capecitabine
   2. Drug: oxaliplatin
   3. Drug: sunitinib malate

2. type

   EXPERIMENTAL

   label

   B

   interventionNames

   1. Drug: capecitabine
   2. Drug: cisplatin
   3. Drug: sunitinib malate

Primary outcomes (1)

1. measure

   Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)

   timeFrame

   Baseline up to Day 21

   description

   Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having \>3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery \>14 days.