Trastuzumab in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer

February 27, 2013 updated by: National Cancer Institute (NCI)

Phase II Study of Trastuzumab (NSC-688097) in Advanced High Grade Salivary Gland Carcinoma

This phase II trial is studying how well trastuzumab works in treating patients with metastatic or recurrent salivary gland cancer. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To assess response (confirmed and unconfirmed, complete and partial response) in patients with advanced high-grade salivary gland carcinoma treated with trastuzumab.

II. To assess one-year progression-free survival and one-year overall survival for patients treated with this regimen.

III. To assess the toxicities associated with this treatment regimen in this group of patients.

IV. To measure the indicators of C-erb B2 oncoprotein expression and C-erb B2 oncogene amplification and epidermal growth factor receptor expression and explore the relationship between these markers and response, progression-free survival and overall survival in preliminary fashion.

OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 8 weeks until disease progression and then every 3 months for 1 year and every 6 months until 3 years from study entry.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78245
        • Southwest Oncology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed malignant high-grade (poorly differentiated or undifferentiated) salivary gland carcinoma of the head and neck (except adenoid cystic carcinoma) that is either metastatic or recurrent and is not amenable to salvage surgical resection or radiation therapy; eligible histologies are adenocarcinoma, acinic cell carcinoma, mucoepidermoid carcinoma, salivary duct carcinoma and undifferentiated carcinoma
  • Patients must have tumors that car HER-2 gene amplification as determined by (i) fluorescence in situ hybridization (FISH) or (ii) overexpression of HER-2 protein, 2+ to 3+ level assessed by immunohistochemistry
  • Patients must have measurable disease; all measurable disease must be assessed within 28 days prior to registration; all non-measurable disease must be assessed within 42 days prior to registration
  • Patients with known brain metastases are not eligible for this trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • Patients must have and must be willing to submit tumor tissue for pathology review and translational medicine studies; patients must be offered the opportunity to participate in specimen banking for future research
  • Patients previously treated with chemotherapy are eligible provided that at least (28 days) has elapsed since the last course of chemotherapy was completed and patient has recovered from all toxicities
  • Prior radiation must have been completed at least 28 days prior to registration and all toxicities must have resolved (in the opinion of the treating investigator); prior surgery must have been completed at least 28 days prior to registration and all surgical adverse events must have resolved (in the opinion of the treating investigator)
  • Patients must not be planning on receiving any other investigational agents, other chemotherapeutic agents, radiation therapy, or hormonal therapy while receiving treatment on this study except for steroids administered for non-disease-related conditions (e.g., insulin for diabetes)
  • Patients must have a Zubrod Performance status of 0-2
  • WBC count >= 2,000 ul within 28 days prior to registration
  • ANC count >= 1,000/ul within 28 days prior to registration
  • Platelet count >= 75,000/ul within 28 days prior to registration
  • Bilirubin =< 2.5 x the institutional upper limit of normal within 28 days prior to registration
  • SGOT or SGPT =< 2.5 x the institutional upper limit of normal within 28 days prior to registration
  • Patients with liver metastases must have bilirubin and SGOT or SGPT =< 5 x the institutional upper limit of normal
  • Serum creatinine < 2.5 x the institutional limit of normal within 28 days prior to registration
  • Patients with a known history of allergic reactions to compounds of similar chemical or biologic composition to trastuzumab are not eligible
  • No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years
  • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method
  • If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day
  • In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • At the time of patient registration, the treating institution's name and ID number must be provided to the data operations center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (trastuzumab)
Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
Correlative studies
Biological: trastuzumab
Given IV
Other Names:
  • Herceptin
  • anti-c-erB-2
  • MOAB HER2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response (confirmed and unconfirmed, complete and partial response) in patients treated with trastuzumab
Time Frame: Up to 4 years
A true response probability of 30% or greater would be of interest.
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Up to 4 years
Up to 4 years
Progression-free survival
Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 1 year
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Madeleine Kane, Southwest Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

August 2, 2005

First Submitted That Met QC Criteria

August 2, 2005

First Posted (Estimate)

August 4, 2005

Study Record Updates

Last Update Posted (Estimate)

February 28, 2013

Last Update Submitted That Met QC Criteria

February 27, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-03172
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S0431
  • CDR0000437831 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrent Salivary Gland Cancer

Clinical Trials on laboratory biomarker analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe