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Herceptin In Patients With Advanced or Metastatic Salivary Gland Carcinomas

Phase 2
18 Years
Open (Enrolling)
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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Marshall R. Posner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Federal Government

Study ID:




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



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Washington University Barnard Cancer Center Saint Louis, Missouri  63110
Lourdes Regional Cancer Center Binghamton, New York  13905
Yale-New Haven Hospital New Haven, Connecticut  06504
Hematology/Oncology Associates Port Saint Lucie, Florida  34952
Cape Cod Health Care Hyannis, Massachusetts  02601
Nantucket Cottage Hospital Nantucket, Massachusetts  02554