Trastuzumab in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer
High-grade Salivary Gland Mucoepidermoid Carcinoma
Recurrent Salivary Gland Cancer
Salivary Gland Acinic Cell Tumor
Salivary Gland Adenocarcinoma
Salivary Gland Poorly Differentiated Carcinoma
Stage IVA Salivary Gland Cancer
Stage IVB Salivary Gland Cancer
Stage IVC Salivary Gland Cancer
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Trastuzumab (NSC-688097) in Advanced High Grade Salivary Gland Carcinoma|
- Response (confirmed and unconfirmed, complete and partial response) in patients treated with trastuzumab [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]A true response probability of 30% or greater would be of interest.
- 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 ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Experimental: Treatment (trastuzumab)
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.
Other Names:Other: laboratory biomarker analysis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126607
|United States, Texas|
|Southwest Oncology Group|
|San Antonio, Texas, United States, 78245|
|Principal Investigator:||Madeleine Kane||Southwest Oncology Group|