An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma

Study Overview
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Brief Summary
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This study is a multicentre, open label, non-comparative, two stage phase II trial to assess the activity of ZD1839 (IRESSA) in patients with malignant mesothelioma. Patients will receive trial treatment as first-line therapy, administered continuously once daily until the completion of six 4-week cycles of treatment, disease progression, unacceptable toxicity or withdrawal of consent. Patients continuing to show evidence of response, disease stabilization or clinical benefit from ZD1839 may continue to receive therapy beyond completion of the trail.

Official Title
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An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma

Conditions
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Mesothelioma

Intervention / Treatment
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* Drug: ZD1839


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically-confirmed malignant mesothelioma (based on pleural biopsy); eligibility for first line therapy for malignant mesothelioma Uni or bi- dimensionally measurable disease No prior radiotherapy within 3 weeks of enrolment into the trial No significant comorbid disease Exclusion Criteria: Other malignancies, either co-existing or diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ Brian metastasis or leptomeningeal carcinomatosis Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, or St. John's Wort

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: 1<br> | Drug: ZD1839<br>* 250mg tablet, once daily, orally administered<br>* Other names: IRESSA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the activity of ZD1839 in patients with malignant mesothelioma by estimating the objective response rate (CR and PR) at trial closure |  | Proportion of patients responding at trial closure, ITT population | 
| To further characterize the safety profile of ZD1839 at a 250mg daily dose |  | Proportion of patients responding at trial closure, ITT population | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate PFS (progression free survival) |  | Proportion of patients alive and progression-free at trial closure, ITT population; Median time to progression or death; Proportion of patients alive and progression-free at 6 months | 
| To estimate overall survival |  | Proportion of patients alive at trial closure, ITT population; Median time to death; Proportion of patients alive at 6 months | 
| To estimate duration of response |  | Median time from objective response to progression or death; only patients who responded are included in this analysis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malignant mesothelioma, IRESSA, ZD1839