Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004163
First received: December 10, 1999
Last updated: February 6, 2009
Last verified: December 2001
  Purpose

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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Herceptin In Patients With Advanced or Metastatic Salivary Gland Carcinomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004163

Locations
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
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Cape Cod Health Care
Hyannis, Massachusetts, United States, 02601
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
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Marshall R. Posner, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00004163     History of Changes
Other Study ID Numbers: CDR0000067405, DFCI-98286, NCI-G99-1628
Study First Received: December 10, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014