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Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Genentech, Inc.
Information provided by (Responsible Party):
Robert I. Haddad, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00004163
First received: December 10, 1999
Last updated: April 14, 2017
Last verified: April 2017
  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 Drug: Trastuzumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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 Robert I. Haddad, MD, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Time to Progression [ Time Frame: 2 years ]
  • Toxicity [ Time Frame: 2 years ]

Enrollment: 14
Actual Study Start Date: October 1999
Study Completion Date: September 2001
Primary Completion Date: September 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trastuzumab
  • Trastuzumab is administered intravenously weekly
  • CAT or MRI scans will be performed every 2 cycles
Drug: Trastuzumab
Other Name: Herceptin

Detailed Description:

Due to the age of this study upon transfer from the NCI to DFCI, data was not accessible to find the exact primary completion date (PCD) or study completion date (SCD). The September 2001 date used for both is based on known enrollment dates and an estimate on median time to progression (TTP) in the setting of this clinical trial. Since participants were treated indefinitely until progression, TTP is deemed to reflect generally the time on treatment for evaluation of the primary response outcome. Furthermore, patients were followed for progression to estimate TTP, a secondary outcome measure.

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).

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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Histologic diagnosis of any of the following malignancies originating from salivary tissue: adenoid cystic carcinoma, mucoepidermoid carcinoma, acinic cell carcinoma, malignant mixed tumor, polymorphous low grade adenocarcinoma, undifferentiated carcinoma, squamous cell carcinoma, adenocarcinoma.
  • Her2/neu determination: Patients must have overexpression of the Her2/neu protein in the tumor documented by the Dako polyclonal rabbit anti-Her2 antisera assay.

Overexpression may be documented by staining of the original paraffin embedded tumor from the time of diagnosis or from material obtained at the time of locoregional or distant recurrence.

Overexpression of HER2/neu will be per the Dako Herceptest guidelines. A Score of 2+ or 3+ will be defined as overexpression. All slides will be reviewed by members of the departments of pathology at either the Brigham and Women's Hospital or the Beth Israel Hospital in Boston.

  • Patients must be incurable on the basis of unresectable local or distant disease as determined by the patient's surgeon.
  • Patients must have an ECOG performance status of 0 to 1.
  • Patients must have at least uni-dimensionally measurable disease documented within one month of initiation of treatment. Measurement may be by physical exam or radiologically. Attempts should be made to photo document all tumor sites assessed by physical examination with a metric ruler within the photo for measurement confirmation.
  • Patients must be willing and able to go through the process of informed consent.
  • Patients must have a life expectancy exceeding 3 months.
  • Patients must be at least 18 years old.
  • Patients must have adequate organ function as defined by the following tests to be performed within 14 days of therapy initiation:

    • Absolute neutrophil count > 1999 cells x 10 61L
    • Platelet count > 99,999 cells x 106/L
    • Hemoglobin >8.5 gm/di or HCT > 25%
    • Serum creatinine < 1.5 x institutional upper limits of normal (ULN) or creatinine clearance measured by 24 hour urine collection as at least 50% of institutional lower limit of normal.
    • Total bilirubin <2 x institutional ULN
    • AST (SGOT) < 2 x institutional ULN *
  • If from documented liver involvement with cancer, may be up to < 5 x institutional ULN Alkaline Phosphatase < 5 x institutional ULN *
  • If from documented bone or liver involvement with cancer, no upper limit restriction.
  • Baseline determination of normal left ventricular ejection fraction as evidenced MUGA or echocardiogram.

Exclusion Criteria:

  • Patients must not have received more than two regimens of cytotoxic chemotherapy for salivary gland cancer. Previous immunologic, hormonal, homeopathic, natural, or alternative medicine therapies are acceptable provided treatment ended greater than 28 days prior to protocol therapy.
  • Patients must not receive any form (including radiotherapeutic, immunologic, hormonal, homeopathic, natural, or alternative medicine) of anti-neoplastic therapy other than Herceptin while participating in this study.
  • Patients must not have a history of any non-salivary invasive neoplasm within three years of trial entry, excepting curatively treated non-melanoma skin cancer and cervical cancer.
  • Pregnant and breast feeding women are not eligible for this study. No pregnancy test is required. Women of childbearing potential must be counseled on the use of effective birth control prior to participation in this study.
  • Patients with significant active illness (e.g. congestive heart failure, COPD, uncontrolled diabetes, AIDS, previous MI, cardiomyopathies, history of uncontrolled arrhythmias) are not eligible for this study.
  • Patients who have received anthracyclines (e.g. doxorubicin, daunorubicin, epirubicin) are eligible but must have a baseline MUGA scan documenting normal cardiac contractility (at or above the normal institutional limit) within one month of trial enrollment. The upper limit of doxorubicin exposure should be no more than 360mg1m2
  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
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
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
National Cancer Institute (NCI)
Genentech, Inc.
Investigators
Study Chair: Marshall R. Posner, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Robert I. Haddad, MD, Haddad, Robert MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00004163     History of Changes
Other Study ID Numbers: 98-286
P30CA006516 ( US NIH Grant/Contract Award Number )
NCI-G99-1628
CDR0000067405 ( Other Identifier: Other )
Study First Received: December 10, 1999
Last Updated: April 14, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert I. Haddad, MD, Dana-Farber Cancer Institute:
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
Salivary Gland Neoplasms
Neoplasms by Site
Neoplasms
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Trastuzumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 23, 2017