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


Phase 2
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response (confirmed and unconfirmed, complete and partial response) in patients treated with trastuzumab

Outcome Description:

A true response probability of 30% or greater would be of interest.

Outcome Time Frame:

Up to 4 years

Safety Issue:

No

Principal Investigator

Madeleine Kane

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03172

NCT ID:

NCT00126607

Start Date:

July 2005

Completion Date:

Related Keywords:

  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Acinar Cell
  • Carcinoma, Mucoepidermoid
  • Salivary Gland Neoplasms

Name

Location

Southwest Oncology GroupSan Antonio, Texas  78245