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Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer

This study is ongoing, but not recruiting participants.
Study NCT00004163.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer
Official Title  Herceptin In Patients With Advanced or Metastatic Salivary Gland Carcinomas
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

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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Head and Neck Cancer
Intervention  Drug: trastuzumab
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  January 1999
Completion Date
Eligibility Criteria 

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

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00004163
Organization ID CDR0000067405
Secondary IDs †† DFCI-98286, NCI-G99-1628
Study Sponsor  Dana-Farber Cancer Institute
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Marshall R. Posner, MD     Dana-Farber Cancer Institute    
Information Provided By National Cancer Institute (NCI)
Verification Date December 2001
First Received Date  December 10, 1999
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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