A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to find out what effects (good and bad) ZD1839 has on one's squamous cell head and neck cancer. The research is being done because currently no effective treatment exists for metastatic (spread of cancer cells from one area of the body to another) or recurrent squamous cell cancer of the head and neck. The purpose of this study is to find out if ZD1839 can shrink tumors or cause tumors to stop growing for a period of time.

Official Title
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A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: ZD1839 (IRESSA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed squamous cell carcinoma of the head and neck incurable by surgery or radiation Patients must have measurable disease, defined as at least on e lesion that can be accurately measured in the one dimension (longer diameter to be recorded) as greater then or equal to 20mm with conventional techniques or as greater than or equal to 10mm with computed tomograpy (CT) scan. Therapeutic history that includes the Following: No prior EGFR-based therapy for recurrent disease No chemotherapy or irradiation with the 28-day period preceding entry to the study Eastern Cooperative Oncology Group (ECOG)performance Status 0-2 (kamofsky >59%) Patients must have normal organ and marrow function as defined below: leukocytes >3,000ml absolute neutrophil count 1,500/ml platelets 100,000/ml total bilirubin within normal institutional limits AST(SGOT)ALT(SGPT) <2.5 X institutional upper limits of normal Creatinine <1.5 Exclusion Criteria: Other coexisting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical in situ. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, ketoconazole, erythromycin, clarithromycin, atorvastatin, cimetidine, ametidine, amitriptyline, imipramine, verpamil, tamoxifen, chlorpromazine, amiodorone, chloroquine, St. John's Wort Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy Incomplete healing from previous oncologic or other major surgery Patients may not be receiving any other investigational agents History of allergic reactions attributed to compound of similar chemical or biologic composition to ZD 1839 Uncontrolled intercurrent illness Pregnancy or breast feeding (women of child -bearing potential

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZD1839 (IRESSA) 250mg<br>ZD1839(IRESSA) 250mg orally (po) daily | Drug: ZD1839 (IRESSA)<br>* ZD1839: 250mg/day po or via g-tube Q 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the activity of 250mg of ZD1839 administered as a single agent to patients with recurrent or metastatic or both recurrent and metastatic head and neck cancer. |  | 2 -5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the effectiveness of ZD 1839 as an inhibitor of epithelial growth factor (EGFR) phosphorylation, MAP kinase activation, and vascular endothelial growth (VEGF) secretion in metastatic head and neck cancer. |  | 2-5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Larynx, Lip, Oral Cavity and Pharynx