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

• Status: Terminated
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Trastuzumab

Criteria

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)