Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer
Herceptin In Patients With Advanced or Metastatic Salivary Gland Carcinomas
4 other identifiers
interventional
14
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 head-and-neck-cancer
Started Oct 1999
Shorter than P25 for phase_2 head-and-neck-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1999
CompletedFirst Submitted
Initial submission to the registry
December 10, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2001
CompletedFirst Posted
Study publicly available on registry
March 15, 2004
CompletedApril 18, 2017
April 1, 2017
1.9 years
December 10, 1999
April 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response Rate
2 years
Secondary Outcomes (2)
Time to Progression
2 years
Toxicity
2 years
Study Arms (1)
Trastuzumab
EXPERIMENTAL* Trastuzumab is administered intravenously weekly * CAT or MRI scans will be performed every 2 cycles
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +5 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
- Genentech, Inc.collaborator
Study Sites (10)
Yale-New Haven Hospital
New Haven, Connecticut, 06504, United States
Hematology/Oncology Associates
Port Saint Lucie, Florida, 34952, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Cape Cod Health Care
Hyannis, Massachusetts, 02601, United States
Nantucket Cottage Hospital
Nantucket, Massachusetts, 02554, United States
Washington University Barnard Cancer Center
St Louis, Missouri, 63110, United States
Lourdes Regional Cancer Center
Binghamton, New York, 13905, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marshall R. Posner, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Haddad, Robert MD
Study Record Dates
First Submitted
December 10, 1999
First Posted
March 15, 2004
Study Start
October 1, 1999
Primary Completion
September 1, 2001
Study Completion
September 1, 2001
Last Updated
April 18, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share