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Trastuzumab in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer

Primary Purpose

High-grade Salivary Gland Mucoepidermoid Carcinoma, Recurrent Salivary Gland Cancer, Salivary Gland Acinic Cell Tumor

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
trastuzumab
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High-grade Salivary Gland Mucoepidermoid Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (trastuzumab)

Arm Description

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.

Outcomes

Primary Outcome Measures

Response (confirmed and unconfirmed, complete and partial response) in patients treated with trastuzumab
A true response probability of 30% or greater would be of interest.

Secondary Outcome Measures

Progression-free survival
Overall survival

Full Information

First Posted
August 2, 2005
Last Updated
February 27, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00126607
Brief Title
Trastuzumab in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer
Official Title
Phase II Study of Trastuzumab (NSC-688097) in Advanced High Grade Salivary Gland Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual.
Study Start Date
July 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-grade Salivary Gland Mucoepidermoid Carcinoma, Recurrent Salivary Gland Cancer, Salivary Gland Acinic Cell Tumor, Salivary Gland Adenocarcinoma, Salivary Gland Poorly Differentiated Carcinoma, Stage IVA Salivary Gland Cancer, Stage IVB Salivary Gland Cancer, Stage IVC Salivary Gland Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (trastuzumab)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
trastuzumab
Other Intervention Name(s)
anti-c-erB-2, Herceptin, MOAB HER2
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response (confirmed and unconfirmed, complete and partial response) in patients treated with trastuzumab
Description
A true response probability of 30% or greater would be of interest.
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
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
Title
Overall survival
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madeleine Kane
Organizational Affiliation
SWOG Cancer Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Oncology Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78245
Country
United States

12. IPD Sharing Statement

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Trastuzumab in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer

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