Spots Global Cancer Trial Database for Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer

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Trial Identification

Brief Title: Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer

Official Title: Herceptin In Patients With Advanced or Metastatic Salivary Gland Carcinomas

Study ID: NCT00004163

Conditions

Head and Neck Cancer

Interventions

Trastuzumab

Study Description

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.

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.