Trial information
A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer
Status: Recruiting
Protocol number: ML17600
Sponsor: Hoffmann-La Roche AG
Company division: Pharmaceutical
Official Scientific Title: An open-label pilot study evaluating the effect of a combination regimen of Herceptin, cisplatin, and gemcitabine on time to disease progression in patients with metastatic urothelial cancer
Brief 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 and the target sample size is <100 individuals.
Target sample size is 22.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Urinary Tract Cancer
Intervention type: Drug
Intervention name: trastuzumab[Herceptin]
Primary outcome: 1. Time to progression.
Key secondary outcomes: 1. Efficacy: Clinical benefit rate: complete remission, partial remission, or stable disease; and overall survival.
Safety: Toxicity profile (systemic and cardiac tolerability); and quality of life
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;
- women who are pregnant or breastfeeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: January, 2001
Trial registration date: 08/29/2005
Date last updated: 10/15/2008
Link to trial result
This trial is being conducted at the following locations:
Germany
- Aschersleben
- Dessau
- Fulda
- Leipzig
- Marburg
- Regensburg
- Weiden
