Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Herceptin In Patients With Advanced or Metastatic Salivary Gland Carcinomas|
- Response Rate [ Time Frame: 2 years ]
- Time to Progression [ Time Frame: 2 years ]
- Toxicity [ Time Frame: 2 years ]
|Actual Study Start Date:||October 1999|
|Study Completion Date:||September 2001|
|Primary Completion Date:||September 2001 (Final data collection date for primary outcome measure)|
Other Name: Herceptin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004163
|United States, Connecticut|
|Yale-New Haven Hospital|
|New Haven, Connecticut, United States, 06504|
|United States, Florida|
|Port Saint Lucie, Florida, United States, 34952|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Cape Cod Health Care|
|Hyannis, Massachusetts, United States, 02601|
|Nantucket Cottage Hospital|
|Nantucket, Massachusetts, United States, 02554|
|United States, Missouri|
|Washington University Barnard Cancer Center|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Lourdes Regional Cancer Center|
|Binghamton, New York, United States, 13905|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Marshall R. Posner, MD||Dana-Farber Cancer Institute|