Phase II Study of Trastuzumab (NSC-688097) in Advanced High Grade Salivary Gland Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- High-grade Salivary Gland Mucoepidermoid Carcinoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Response (confirmed and unconfirmed, complete and partial response) in patients treated with trastuzumab
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have histologically or cytologically confirmed malignant high-grade (poorly differentiated or undifferentiated) salivary gland carcinoma of the head and neck (except adenoid cystic carcinoma) that is either metastatic or recurrent and is not amenable to salvage surgical resection or radiation therapy; eligible histologies are adenocarcinoma, acinic cell carcinoma, mucoepidermoid carcinoma, salivary duct carcinoma and undifferentiated carcinoma
- •Patients must have tumors that car HER-2 gene amplification as determined by (i) fluorescence in situ hybridization (FISH) or (ii) overexpression of HER-2 protein, 2+ to 3+ level assessed by immunohistochemistry
- •Patients must have measurable disease; all measurable disease must be assessed within 28 days prior to registration; all non-measurable disease must be assessed within 42 days prior to registration
- •Patients with known brain metastases are not eligible for this trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- •Patients must have and must be willing to submit tumor tissue for pathology review and translational medicine studies; patients must be offered the opportunity to participate in specimen banking for future research
- •Patients previously treated with chemotherapy are eligible provided that at least (28 days) has elapsed since the last course of chemotherapy was completed and patient has recovered from all toxicities
- •Prior radiation must have been completed at least 28 days prior to registration and all toxicities must have resolved (in the opinion of the treating investigator); prior surgery must have been completed at least 28 days prior to registration and all surgical adverse events must have resolved (in the opinion of the treating investigator)
- •Patients must not be planning on receiving any other investigational agents, other chemotherapeutic agents, radiation therapy, or hormonal therapy while receiving treatment on this study except for steroids administered for non-disease-related conditions (e.g., insulin for diabetes)
- •Patients must have a Zubrod Performance status of 0-2
- •WBC count \>= 2,000 ul within 28 days prior to registration
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Progression-free survival(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(Up to 4 years)