Recurrent Salivary Gland Cancer Clinical Trial
Official title:
Phase II Study of Trastuzumab (NSC-688097) in Advanced High Grade Salivary Gland Carcinoma
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
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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