Trial Information

Summary: 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 Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Single Group
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

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

Accepts Healthy Volunteers: No

Anticipated Start Date: January, 2001

Trial Registration Date: 08/29/2005

Date Last Updated: 09/19/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Leipzig, Germany, 04229
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: October 6, 2008 at 2:48:39 PM


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