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Herceptin In Patients With Advanced or Metastatic Salivary Gland Carcinomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

Herceptin In Patients With Advanced or Metastatic Salivary Gland Carcinomas


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Marshall R. Posner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067405

NCT ID:

NCT00004163

Start Date:

January 1999

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Head and Neck Neoplasms
  • Salivary Gland Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Washington University Barnard Cancer CenterSaint Louis, Missouri  63110
Lourdes Regional Cancer CenterBinghamton, New York  13905
Yale-New Haven HospitalNew Haven, Connecticut  06504
Hematology/Oncology AssociatesPort Saint Lucie, Florida  34952
Cape Cod Health CareHyannis, Massachusetts  02601
Nantucket Cottage HospitalNantucket, Massachusetts  02554