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| Tracking Information | |||||
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| First Received Date ICMJE | December 10, 1999 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | January 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004163 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer | ||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Head and Neck Cancer | ||||
| Intervention ICMJE | Biological: trastuzumab | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004163 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067405, DFCI-98286, NCI-G99-1628 | ||||
| Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | December 2001 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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