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

Phase 2

Completed

• Conditions: Mesothelioma
• Interventions: Drug: ZD1839

• Registration Number: NCT00787410
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2008-11-06
• Study First Submitted QC: 2008-11-06
• Study First Posted: 2008-11-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ZD1839	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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