Iressa Study in Patients With Salivary Gland Cancer
Condition: Salivary Gland Cancer
MeSH terms: Salivary Gland Neoplasms
Intervention: Gefitinib
Intervention description: 250 mg by mouth once a day, every day, at about same time in morning.
Intervention MeSH terms: Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Healthy volunteers: No
Keywords: Salivary Gland Cancer; Iressa; ZD1839

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.
    

Eligibility criteria:

        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).