Trials / Terminated
TerminatedNCT00126607
Trastuzumab in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer
Phase II Study of Trastuzumab (NSC-688097) in Advanced High Grade Salivary Gland Carcinoma
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | trastuzumab | Given IV |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2007-05-01
- First posted
- 2005-08-04
- Last updated
- 2013-02-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00126607. Inclusion in this directory is not an endorsement.