Clinical Trial: Trastuzumab in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase II Study of Trastuzumab (NSC-688097) in Advanced High Grade Salivary Gland Carcinoma

Brief Summary: This phase II trial is studying how well trastuzumab works in treating patients with metastatic or recurrent salivary gland cancer. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them

Detailed Summary:

PRIMARY OBJECTIVES:

I. To assess response (confirmed and unconfirmed, complete and partial response) in patients with advanced high-grade salivary gland carcinoma treated with trastuzumab.

II. To assess one-year progression-free survival and one-year overall survival for patients treated with this regimen.

III. To assess the toxicities associated with this treatment regimen in this group of patients.

IV. To measure the indicators of C-erb B2 oncoprotein expression and C-erb B2 oncogene amplification and epidermal growth factor receptor expression and explore the relationship between these markers and response, progression-free survival and overall survival in preliminary fashion.

OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 8 weeks until disease progression and then every 3 months for 1 year and every 6 months until 3 years from study entry.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Response (confirmed and unconfirmed, complete and partial response) in patients treated with trastuzumab [ Time Frame: Up to 4 years ]

A true response probability of 30% or greater would be of interest.


Original Primary Outcome:

Current Secondary Outcome:

  • Progression-free survival [ Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 1 year ]
  • Overall survival [ Time Frame: Up to 4 years ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: August 2, 2005
Date Started: July 2005
Date Completion:
Last Updated: February 27, 2013
Last Verified: February 2013