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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004163 |
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.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer |
Biological: trastuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Herceptin In Patients With Advanced or Metastatic Salivary Gland Carcinomas |
Study Start Date: | January 1999 |
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).
Patients receive trastuzumab IV over 30-90 minutes weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven locally unresectable or metastatic malignancy arising from salivary tissue Adenoid cystic carcinoma Polymorphous low grade adenocarcinoma Mucoepidermoid carcinoma Undifferentiated carcinoma Acinic cell carcinoma Squamous cell carcinoma Malignant mixed tumor Adenocarcinoma Unidimensionally measurable disease Overexpression of Her2/neu protein
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count greater than 1999/mm3 Platelet count greater than 99,999/mm3 Hemoglobin greater than 8.5 g/dL OR Hematocrit greater than 25% Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than 2 times ULN (less than 5 times ULN if liver involvement) Alkaline phosphatase less than 5 times ULN (no restriction if bone or liver involvement) Renal: Creatinine less than 1.5 times ULN OR Creatinine clearance at least 50% lower limit of normal Cardiovascular: Must have normal cardiac contractility by MUGA if received prior anthracyclines (doxorubicin, daunorubicin, epirubicin) No congestive heart failure Pulmonary: No chronic obstructive pulmonary disease Other: No prior other malignancy with past 3 years except curatively treated nonmelanoma skin cancer or cervical cancer No significant active illness No uncontrolled diabetes No AIDS Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunologic therapy No other concurrent immunologic therapy Chemotherapy: No more than 2 prior regimens of cytotoxic chemotherapy for salivary gland cancer No prior doxorubicin of more than 360 mg/m2 No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal therapy No concurrent hormonal therapy Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: At least 4 weeks since prior homeopathic, natural, or alternative medicine therapy No concurrent homeopathic, natural, or alternative medicine therapy
United States, Connecticut | |
Yale-New Haven Hospital | |
New Haven, Connecticut, United States, 06504 | |
United States, Florida | |
Hematology/Oncology Associates | |
Port Saint Lucie, Florida, United States, 34952 | |
United States, Massachusetts | |
Cape Cod Health Care | |
Hyannis, Massachusetts, United States, 02601 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 | |
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 |
Study ID Numbers: | CDR0000067405, DFCI-98286, NCI-G99-1628 |
Study First Received: | December 10, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004163 History of Changes |
Health Authority: | United States: Federal Government |
stage III salivary gland cancer stage IV salivary gland cancer recurrent salivary gland cancer salivary gland squamous cell carcinoma salivary gland acinic cell tumor low-grade salivary gland mucoepidermoid carcinoma |
high-grade salivary gland mucoepidermoid carcinoma salivary gland adenocarcinoma salivary gland poorly differentiated carcinoma salivary gland malignant mixed cell type tumor salivary gland adenoid cystic carcinoma |
Mouth Diseases Squamous Cell Carcinoma Mouth Neoplasms Recurrence Oral Cancer Carcinoma Salivary Gland Neoplasms Carcinoma, Adenoid Cystic |
Head and Neck Neoplasms Epidermoid Carcinoma Trastuzumab Adenoid Cystic Carcinoma Stomatognathic Diseases Carcinoma, Squamous Cell Adenocarcinoma Salivary Gland Diseases |
Mouth Diseases Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Head and Neck Neoplasms |
Trastuzumab Stomatognathic Diseases Mouth Neoplasms Salivary Gland Diseases Pharmacologic Actions Salivary Gland Neoplasms |