A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression

• Status: Terminated
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or advanced gastric cancer with disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy. The anticipated time on study treatment is until disease progression.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• adult patients 18-75 years of age;

• metastatic or advanced gastric cancer;

• disease progression under or after 1 prior platinum-based or 5-fluoropyrimidine-based chemotherapy for metastatic disease;

• >=4 weeks from last platinum-based or fluoropyrimidine-based chemotherapy;

• >=1 measurable lesion;

• HER2 overexpression (IHC [2+] or [3+]).

Exclusion Criteria:

• concurrent chemotherapy or immunotherapy;

• brain or meningeal metastases;

• clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;

• co-existing malignancies or malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ;

• women who are pregnant or breastfeeding.