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Spots Global Cancer Trial Database for Trastuzumab in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer

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Trial Identification

Brief Title: Trastuzumab in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer

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

Study ID: NCT00126607

Study Description

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 Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Southwest Oncology Group, San Antonio, Texas, United States

Contact Details

Name: Madeleine Kane

Affiliation: SWOG Cancer Research Network

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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