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Salivary Gland CancerPhase 2NCT00509002

Iressa Study in Patients With Salivary Gland Cancer

A Phase 2 study testing Gefitinib in people with Salivary Gland Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Salivary Gland Cancer
What is being tested?
Gefitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
May 2004to Sep 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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, ketoconazole)
  • 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.
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  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this 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)

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.

Read the 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.

Being tested
Gefitinib
Keywords
Salivary Gland Cancer, Iressa, ZD1839
Medical subject headings
Salivary Gland Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GefitinibDrug

    Also called Iressa, ZD1839

    250 mg by mouth once a day, every day, at about same time in morning.

Study groups in NCT00509002
Study groupRoleWhat they receive
Adenoid Cystic Salivary Gland Carcinoma GroupExperimentalParticipants receive Gefitinib daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
Receives: Drug: Gefitinib
Other Carcinoma of Salivary Gland GroupExperimentalParticipants receive Gefitinib daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
Receives: Drug: Gefitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2007 (estimated)
  2. Study startMay 2004
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00509002
Sponsor's protocol ID
2004-0089
Other IDs
NCI-2010-00744
Status last verified
Oct 2017
First submitted
26 Jul 2007
Last updated
24 Nov 2017
Data monitoring committee
No

Publications

  • Jakob JA, Kies MS, Glisson BS, Kupferman ME, Liu DD, Lee JJ, El-Naggar AK, Gonzalez-Angulo AM, Blumenschein GR Jr. Phase II study of gefitinib in patients with advanced salivary gland cancers. Head Neck. 2015 May;37(5):644-9. doi: 10.1002/hed.23647. Epub 2015 Mar 30.

    PubMed 24585506

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gefitinib in people with Salivary Gland Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00509002, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.

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