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Phase II Study of ZD1839 (Iressa®), Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor in Patients With Advanced, Recurrent or Metastatic Salivary Gland Cancer (IRUSIRES0198)

Phase 2
Open (Enrolling)
Salivary Gland Cancer

Thank you

Trial Information

Phase II Study of ZD1839 (Iressa®), Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor in Patients With Advanced, Recurrent or Metastatic Salivary Gland Cancer (IRUSIRES0198)

Epidermal growth factor receptor (EGFR) may be involved in certain types of cancer,
including squamous cell carcinoma of the skin. When EGFR is stimulated, a series of
chemical reactions starts that results in a tumor being "told" to grow. ZD1839 (Iressa® or
Gefitinib) tries to stop these reactions by blocking EGFR. This may stop tumors from

Before you can start treatment on the study, you will have what are called "screening
tests". These tests will help the doctor decide if you are eligible to take part in the
study. You will have a physical exam, and a CT scan to check on the size and location of the
tumor. If the diagnosis has not yet been confirmed, a tumor sample (biopsy) may need to be
collected. During this biopsy, a tumor sample and a sample of normal skin will be taken with
a large needle. Women who are able to have children must have a negative blood or urine
pregnancy test.

If you are eligible to take part in this study, you will take gefitinib treatment by mouth
once a day, every day, at about the same time in the morning. It can be taken with or
without food. If you forget to take a dose, the last missed dose should be taken as soon as
you remember, as long as it is at least 12 hours before the next dose is due to be taken.

Every four weeks during treatment, you will have a physical exam and blood (around 3-4
teaspoons) will be collected for routine tests. If you have skin lesions, the lesions will
be measured and photographed for research purposes. You cannot be identified from the
pictures. You will also be asked about any side effects you may be experiencing. If your
doctor feels it is necessary, you may have more frequent check-ups.

Every eight weeks during treatment, you will have imaging tests. The imaging tests include,
a chest x-ray and a CT scan or MRI of the head and neck area. You may also have CT scans of
other areas of the body. These tests are being done to check on the status of the disease.

You will continue to take gefitinib as long as the disease is responding to treatment. If at
any time during the study the disease becomes worse or you experience any intolerable side
effects, you will be taken off the study and your doctor will discuss other treatment
options with you.

Sometimes, new information becomes available that may influence your decision to continue in
the study. The following new information is available:

Results from two large studies showed that there was no benefit from adding gefitinib to
chemotherapy with platinum and one other chemotherapy drug when given as the first treatment
for non-small cell lung cancer (NSCLC). Therefore, gefitinib is not approved for use in
combination with chemotherapy in the treatment of NSCLC.

This is an investigational study. The FDA has authorized gefitinib for use in cancer
research. Up to 80 patients will take part in this study. All will be enrolled at M. D.

Inclusion Criteria:

1. Histologically or cytologically confirmed salivary gland carcinoma.

2. Patients with advanced or recurrent salivary gland cancer who are not candidates for
curative surgery or radiotherapy.

3. Measurable disease per the RECIST criteria. For disease occurring in previously
irradiated field, there must be confirmed progression prior to the date registration
and more than three months after completion of radiotherapy

4. ECOG performance status 0-2.

5. Prior CNS involvement by tumor is permissible if previously treated and clinically
stable for two weeks after completion of treatment.

6. At least a 2-week recovery from prior therapy toxicity.

7. Provision of written informed consent.

8. Childbearing potential either terminated by surgery, radiation, or menopause, or
attenuated by use of an approved contraceptive method (IUD, birth control pills, or
barrier device) during and for 3 months after completion of trial therapy.

Exclusion Criteria:

1. Known severe hypersensitivity to or any of the excipients of this product.

2. Other coexisting malignancies or malignancies diagnosed within the last 5 years, with
the exception of basal cell carcinoma, squamous cell carcinoma of the skin, or
cervical cancer in situ.

3. Concomitant use of phenytoin, carbamazepine, rifampicin, phenobarbital, or St John's
Wort or CYP3A4 (e.g. itraconazole, ketoconazole)

4. Treatment with a investigational drug within 28 days before Day 1 of trial treatment.

5. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer
therapy (except alopecia)

6. Incomplete healing from previous surgery.

7. Serum creatinine level greater than CTC grade 2.

8. Women who are pregnant or breast feeding.

9. Prior or other EGFR inhibiting agents.

10. Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).

11. Any evidence of severe or uncontrolled systemic disease (e.g., unstable or
uncompensated respiratory, cardiac, hepatic, or renal disease).

12. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5
times the ULRR if no demonstrable liver metastases or greater than 5 times the ULRR
in the presence of liver metastases.

13. Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the patient to participate in the trial.

14. Uncontrolled seizure disorder, active neurological disease, or greater than Grade 2

15. Keratoconjunctivitis sicca or incompletely treated eye infection.

16. Abnormal marrow function as defined as absolute neutrophil count <1,500/ul or
platelets <100,000/ul.

17. Second primary malignancy (except in situ carcinoma of the cervix or adequately
treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 3
years previously with no evidence of recurrence; prior low grade [Gleason score less
than 6] localized prostate cancer is allowed).

Type of Study:


Study Design:

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

Outcome Measure:

Response Rate in Patients

Outcome Time Frame:

Every 4 weeks until progressive disease, unacceptable toxicity or patient withdrawal

Safety Issue:


Principal Investigator

George Blumenschein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2004

Completion Date:

Related Keywords:

  • Salivary Gland Cancer
  • Salivary Gland Cancer
  • Iressa
  • ZD1839
  • Salivary Gland Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030