A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer

An Open-label, Multicentre Phase IV Study of Trastuzumab in Combination With the Standard Therapy (as Per Routine Clinical Practice) as First-line Therapy in Patients With HER2 Positive Metastatic Gastric Cancer

This open-label, multi-center study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction. Patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg Herceptin as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression.

Inclusion Criteria:

• Adult patients, >/=18 years of age
• Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with advanced or metastatic disease, not amenable to curative therapy
• Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
• HER2 positive tumor (primary tumor or metastasis
• ECOG Performance status 0, 1 or 2
• Life expectancy of at least 3 months

Exclusion Criteria:

• Previous chemotherapy for advanced or metastatic disease less than 6 month before study start
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (patients with partial or total gastrectomy are allowed to participate in the study)
• Patients with active (significant or uncontrolled) gastrointestinal bleeding
• Residual relevant toxicity resulting from previous chemotherapy
• Other malignancy within the last 5 years (except carcinoma in situ of the cervix, or basal cell carcinoma)