Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004163
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
1999-12-10
Brief Title:
Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Herceptin In Patients With Advanced or Metastatic Salivary Gland Carcinomas
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase II trial to study the effectiveness of trastuzumab in treating patients who have advanced salivary gland cancer
PURPOSE Phase II trial to study the effectiveness of trastuzumab in treating patients who have advanced salivary gland cancer
Detailed Description:
Due to the age of this study upon transfer from the NCI to DFCI data was not accessible to find the exact primary completion date PCD or study completion date SCD The September 2001 date used for both is based on known enrollment dates and an estimate on median time to progression TTP in the setting of this clinical trial Since participants were treated indefinitely until progression TTP is deemed to reflect generally the time on treatment for evaluation of the primary response outcome Furthermore patients were followed for progression to estimate TTP a secondary outcome measure
OBJECTIVES I Determine the response rate to trastuzumab in patients with advanced or metastatic salivary gland cancer II Determine the time to progression in these patients after this regimen III Determine the toxicity of trastuzumab in these patients
OUTLINE Patients are stratified according to histology intercalated duct adenoid cystic carcinoma acinic cell carcinoma malignant mixed tumor polymorphous low grade adenocarcinoma undifferentiated carcinoma adenocarcinoma vs excretory duct squamous cell carcinoma mucoepidermoid carcinoma
PROJECTED ACCRUAL A total of 50 patients 25 per stratum will be accrued for this study
OBJECTIVES I Determine the response rate to trastuzumab in patients with advanced or metastatic salivary gland cancer II Determine the time to progression in these patients after this regimen III Determine the toxicity of trastuzumab in these patients
OUTLINE Patients are stratified according to histology intercalated duct adenoid cystic carcinoma acinic cell carcinoma malignant mixed tumor polymorphous low grade adenocarcinoma undifferentiated carcinoma adenocarcinoma vs excretory duct squamous cell carcinoma mucoepidermoid carcinoma
PROJECTED ACCRUAL A total of 50 patients 25 per stratum will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000067405 | OTHER | Other | httpsreporternihgovquickSearchP30CA006516 |
| P30CA006516 | NIH | None | None |
| NCI-G99-1628 | None | None | None |