Conditions: Neoplasms, Gastrointestinal Tract
Keywords: lapatinib paclitaxel ErbB2 Gastric cancer Advanced gastric cancer
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 273
Healthy volunteers: no

Brief summary:
EGF104578 is two-part study (Pilot part/Randomized part).Pilot part is designed to find the optimal (best) doses of lapatinib and paclitaxel when given together,Randomized part is designed to evaluate the overall survival in patients receiving lapatinib and paclitaxel compared to patients receiving only paclitaxel.

Detailed description:

Arms:
arm 1: 6 pills of lapatinib at 250 mg each once daily and infusion of paclitaxel at 80 mglm2 weekly arm 2: Infusion of paclitaxel at 80 mglm2 weekly

Interventions: intervention 1: Lapatinib intervention 2: Paclitaxel
Intervention descriptions: intervention 1: 6 pills at 250 mg each once daily intervention 2: Infusion at 80 mg/m2 weekly

Protocol document: