Iressa Study in Patients With Salivary Gland Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00509002
Recruitment Status : Completed
First Posted : July 30, 2007
Results First Posted : November 24, 2017
Last Update Posted : November 24, 2017
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if ZD1839 (Iressa®, gefitinib can help to shrink or slow the growth of advanced, recurrent, or metastatic salivary gland cancer. The safety of this drug will also be studied.

Condition or disease Intervention/treatment Phase
Salivary Gland Cancer Drug: Gefitinib Phase 2

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. ZD1839 (Iressa® or Gefitinib) tries to stop these reactions by blocking EGFR. This may stop tumors from growing.

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. Anderson.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : May 2004
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arm Intervention/treatment
Experimental: Adenoid Cystic Salivary Gland Carcinoma Group
Participants receive Gefitinib daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
Drug: Gefitinib
250 mg by mouth once a day, every day, at about same time in morning.
Other Names:
  • Iressa
  • ZD1839

Experimental: Other Carcinoma of Salivary Gland Group
Participants receive Gefitinib daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
Drug: Gefitinib
250 mg by mouth once a day, every day, at about same time in morning.
Other Names:
  • Iressa
  • ZD1839

Primary Outcome Measures :
  1. Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy [ Time Frame: Every 4 weeks until progressive disease, unacceptable toxicity or patient withdrawal ]
    The modified Response Evaluation Criteria in Solid tumors (RECIST) criteria was used for objective tumor response assessment. Complete Response (CR): Disappearance all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): >20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or > new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Response rate estimated by Gehan's Phase II clinical trial design.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  5. Prior central nervous system (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 neuropathy.
  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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00509002

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: George Blumenschein, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00509002     History of Changes
Other Study ID Numbers: 2004-0089
NCI-2010-00744 ( Registry Identifier: NCI CTRP )
First Posted: July 30, 2007    Key Record Dates
Results First Posted: November 24, 2017
Last Update Posted: November 24, 2017
Last Verified: October 2017

Keywords provided by M.D. Anderson Cancer Center:
Salivary Gland Cancer

Additional relevant MeSH terms:
Salivary Gland Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action