Overview

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.