Trial Information

Summary: Advanced Squamous Cell Cancers of the Head and Neck

Staten Island University Hospital is currently recruiting subjects to participate in a research study for treating HIV positive patients with non-metastatic, advanced squamous cell cancers of the head and neck.

Study drug and procedures will be made available to you at no additional cost.

To qualify, you must:

• Have histologically confirmed non-metastatic squamous cell cancers of the head and neck. Patients with nasopharyngeal cancers would be excluded.
• Be HIV positive.
• Have had no prior chemotherapy, radiation therapy or curative surgery.
• Have ECOG performance status of 0 or 1.
• Have life expectancy of > 12 weeks.
• Have adequate bone marrow and hepatocyte functioning as evidenced by ANC >= 1.5 x 10⁹/liter and Platelet Count >= 100,000 x 10⁹/liter.
• AST/SGOT and/or ALT/SGPT = 2.0 X the upper limit of normal.
• Have Total Bilirubin--Within Normal Limits
• Creatinine <= 1.8
• Be 18 years of age or older (if applicable).
• Have Provision of written informed consent.

You do not qualify if:

• You have a known severe hypersensitivity to ZD1839 or any of the excipients of this product.
• You have, as judged by the investigator, any evidence of severe or uncontrolled systemic disease.
• You have evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.
• Have other coexisting malignancies or malignancies diagnosed within the last 5 years (excludes basal cell carcinoma or cervical cancer in situ)
• Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, Phenobarbital, or St John’s Wort.
• Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
• Have any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
• You have incomplete healing from previous oncologic or other major surgery.
• You are pregnant or breast feeding.
• You have metastatic disease either within the brain or inferior to the clavicles.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.