Trastuzumab in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer

Stopped early · Phase 2

Conditions studied: 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

In brief

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

Key facts

Study ID: NCT00126607
Run by: National Cancer Institute (NCI)
People needed: 35
Starts: 2005-07-01
Last updated by the study team: 2013-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

Southwest Oncology Group — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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