Conditions: Neoplasms, Gastrointestinal Tract
Keywords: unresectable HER2 ErbB2 TYKERB capecitabine CapeOx gastric/esophageal cancer GE junction metastatic lapatinib oxaliplatin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 545
Healthy volunteers: no

Brief summary:
This was an international multi-center trial that enrolled patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors had amplification of the ErbB2 (HER2) gene. The trial investigated whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extended the time to progression and overall survival. Tumor ErbB2 (HER2) status had to be known before trial entry. CapeOx was administered to all patients, and patients were randomly assigned to receive either lapatinib or placebo.

Detailed description:

Arms:
arm 1: CapeOx plus Lapatinib arm 2: CapeOx plus Placebo

Interventions: intervention 1: Lapatinib intervention 2: Placebo intervention 3: Capecitabine intervention 4: Oxaliplatin
Intervention descriptions: intervention 1: 5 pills at 250mg each once daily intervention 2: 5 pills once daily intervention 3: 1700mg/m2/day in two daily doses intervention 4: 130mg/m2 on day 1

Protocol document: