Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126607
Status:
TERMINATED
Last Update Posted:
2013-02-28
First Post:
2005-08-02
Brief Title:
Trastuzumab in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Trastuzumab NSC-688097 in Advanced High Grade Salivary Gland Carcinoma
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000437831 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| S0431 | None | None | None |
| U10CA032102 | NIH | None | None |