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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Given IV
Correlative studies
Southwest Oncology Group
San Antonio, Texas, United States
Response (confirmed and unconfirmed, complete and partial response) in patients treated with trastuzumab
A true response probability of 30% or greater would be of interest.
Time frame: Up to 4 years
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.