A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer

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

Summary

This study will evaluate the efficacy and safety of a chemotherapy regimen of intravenous Herceptin, cisplatin and gemcitabine in patients with metastatic urothelial cancer. The anticipated time on study treatment is until disease progression.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Cisplatin; Gemcitabine; Trastuzumab

Criteria

Inclusion Criteria:

• adult patients with >=18 years of age;

• metastatic urothelial carcinoma;

• measurable metastases or local recurrent disease;

• no prior chemotherapy for metastatic disease;

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

Exclusion Criteria:

• concomitant chemotherapy or immunotherapy;

• active or uncontrolled infection;

• solely CNS metastases;

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

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