Iressa Study in Patients With Salivary Gland Cancer - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center AstraZeneca
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00509002

Purpose

Primary Objective:

1. To determine the response rate of in patients with advanced, recurrent, or metastatic salivary gland cancer who are not candidate for curative surgery or radiotherapy.

Secondary Objectives:

To determine progression-free survival and overall survival.
To determine disease control rate and duration.
To determine time to disease progression.
To further characterize the safety profile of 250 mg daily dose of ZD1839.

Exploratory Objectives:

To demonstrate the effectiveness of ZD1839 as an inhibitor of epithelial growth factor (EGFR) phosphorylation, MAP kinase activation, and vascular endothelial growth factor (VEGF) secretion in salivary gland cancer.
To estimate the correlation of HER2/neu expression and the probability of tumor response.

Condition	Intervention	Phase
Salivary Gland Cancer	Drug: ZD1839 (Iressa)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Salivary Gland Disorders

Drug Information available for: ZD1839

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:	80
Study Start Date:	May 2004

Detailed Description:

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. Gefitinib tries to stop these reactions by blocking EGFR. This may stop tumors from growing.

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. Gefitinib will be provided free of charge during the study. Up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed salivary gland carcinoma.
Patients with advanced or recurrent salivary gland cancer who are not candidates for curative surgery or radiotherapy.
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
ECOG performance status 0-2.
Prior CNS involvement by tumor is permissible if previously treated and clinically stable for two weeks after completion of treatment.
At least a 2-week recovery from prior therapy toxicity.
Provision of written informed consent.
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:

Known severe hypersensitivity to or any of the excipients of this product.
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.
Concomitant use of phenytoin, carbamazepine, rifampicin, phenobarbital, or St John's Wort or CYP3A4 (e.g. itraconazole, ketaconazole)
Treatment with a investigational drug within 28 days before Day 1 of trial treatment.
Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy (except alopecia)
Incomplete healing from previous surgery.
Serum creatinine level greater than CTC grade 2.
Women who are pregnant or breast feeding.
Prior or other EGFR inhibiting agents.
Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).
Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
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.
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.
Uncontrolled seizure disorder, active neurological disease, or greater than Grade 2 neuropathy.
Keratoconjunctivitis sicca or incompletely treated eye infection.
Abnormal marrow function as defined as absolute neutrophil count <1,500/ul or platelets <100,000/ul.
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509002

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

AstraZeneca

Investigators

Principal Investigator:

George Blumenschein, MD

U.T.M.D. Anderson Cancer Center

More Information

No publications provided

Study ID Numbers:	2004-0089
Study First Received:	July 26, 2007
Last Updated:	October 24, 2007
ClinicalTrials.gov Identifier:	NCT00509002 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Salivary Gland Cancer
Iressa
ZD1839

Study placed in the following topic categories:

Mouth Diseases
Head and Neck Neoplasms
Tyrosine
Mitogens
Stomatognathic Diseases
Protein Kinase Inhibitors

Gefitinib
Mouth Neoplasms
Salivary Gland Diseases
Recurrence
Oral Cancer
Salivary Gland Neoplasms

Additional relevant MeSH terms:

Mouth Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Mouth Neoplasms
Protein Kinase Inhibitors
Pharmacologic Actions
Salivary Gland Neoplasms

Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Therapeutic Uses
Stomatognathic Diseases
Salivary Gland Diseases
Gefitinib

ClinicalTrials.gov processed this record on July 02, 2009