Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer

NCT ID: NCT00004163

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2001-09-30

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.

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trastuzumab

• Trastuzumab is administered intravenously weekly
• CAT or MRI scans will be performed every 2 cycles

Group Type: EXPERIMENTAL

Trastuzumab

Intervention Type: DRUG

Interventions

Trastuzumab

Intervention Type: DRUG

Other Intervention Names

Herceptin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Robert I. Haddad, MD

Haddad, Robert MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marshall R. Posner, MD

Role: STUDY_CHAIR

Dana-Farber Cancer Institute

Locations

Yale-New Haven Hospital

New Haven, Connecticut, United States

Hematology/Oncology Associates

Port Saint Lucie, Florida, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Cape Cod Health Care

Hyannis, Massachusetts, United States

Nantucket Cottage Hospital

Nantucket, Massachusetts, United States

Washington University Barnard Cancer Center

St Louis, Missouri, United States

Lourdes Regional Cancer Center

Binghamton, New York, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

P30CA006516

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-G99-1628

Identifier Type: -

Identifier Source: secondary_id

CDR0000067405

Identifier Type: OTHER

Identifier Source: secondary_id

98-286

Identifier Type: -

Identifier Source: org_study_id