Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer
- Registration Number
- NCT00004163
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Not provided
- Patients must not have received more than two regimens of cytotoxic chemotherapy for salivary gland cancer. Previous immunologic, hormonal, homeopathic, natural, or alternative medicine therapies are acceptable provided treatment ended greater than 28 days prior to protocol therapy.
- Patients must not receive any form (including radiotherapeutic, immunologic, hormonal, homeopathic, natural, or alternative medicine) of anti-neoplastic therapy other than Herceptin while participating in this study.
- Patients must not have a history of any non-salivary invasive neoplasm within three years of trial entry, excepting curatively treated non-melanoma skin cancer and cervical cancer.
- Pregnant and breast feeding women are not eligible for this study. No pregnancy test is required. Women of childbearing potential must be counseled on the use of effective birth control prior to participation in this study.
- Patients with significant active illness (e.g. congestive heart failure, COPD, uncontrolled diabetes, AIDS, previous MI, cardiomyopathies, history of uncontrolled arrhythmias) are not eligible for this study.
- Patients who have received anthracyclines (e.g. doxorubicin, daunorubicin, epirubicin) are eligible but must have a baseline MUGA scan documenting normal cardiac contractility (at or above the normal institutional limit) within one month of trial enrollment. The upper limit of doxorubicin exposure should be no more than 360mg1m2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trastuzumab Trastuzumab * Trastuzumab is administered intravenously weekly * CAT or MRI scans will be performed every 2 cycles
- Primary Outcome Measures
Name Time Method Response Rate 2 years
- Secondary Outcome Measures
Name Time Method Toxicity 2 years Time to Progression 2 years
Trial Locations
- Locations (10)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Cape Cod Health Care
🇺🇸Hyannis, Massachusetts, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Hematology/Oncology Associates
🇺🇸Port Saint Lucie, Florida, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Washington University Barnard Cancer Center
🇺🇸Saint Louis, Missouri, United States
Lourdes Regional Cancer Center
🇺🇸Binghamton, New York, United States
Nantucket Cottage Hospital
🇺🇸Nantucket, Massachusetts, United States