Trial Information

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

Status: Completed

Protocol Number: ML17263

Sponsor: Hoffmann-La Roche AG

Company Division: Pharmaceutical

Official Scientific Title: An open-label pilot study of Herceptin monotherapy on objective treatment response in patients with metastatic or locally advanced gastric cancer who had disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy

Brief 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, and the target sample size is<100 individuals. Target sample size is 20.

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: Gastric Cancer

Intervention Type: Drug

Intervention Name: trastuzumab[Herceptin]

Primary Outcome: 1. Efficacy: Tumor response rate (complete and partial response)

Key Secondary Outcomes: 1. Efficacy: Clinical benefit rate; time to progression; duration of response; and survival Safety: Adverse events, left ventricular ejection fraction, assessed by echocardiogram

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.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/29/2005

Date Last Updated: 06/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Wien, Austria, 1090
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 7, 2008 at 2:38:39 PM


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