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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2008-04-30

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.

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Detailed Description

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Conditions

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Mesothelioma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

ZD1839

Intervention Type DRUG

250mg tablet, once daily, orally administered

Interventions

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ZD1839

250mg tablet, once daily, orally administered

Intervention Type DRUG

Other Intervention Names

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IRESSA

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No