ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg) every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800 mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab (Herceptin) will continue until disease progression. The target sample size is 300-600 patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Chugai Pharmaceutical
• Treatments: Capecitabine; Cisplatin; Fluorouracil; Trastuzumab

Criteria

Inclusion Criteria:

• Adult patients >=18 years of age

• Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction

• Adenocarcinoma

• HER2-positive tumors

Exclusion Criteria:

• Previous chemotherapy for advanced/metastatic disease

• Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome

• History of cardiac disease

• Dyspnoea at rest, due to complications of advanced malignancy or other disease, or patients who require supportive oxygen therapy