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

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.

Tracking Information
First Received DateNovember 6, 2008
Last Changed DateJune 5, 2012
Start DateSeptember 2003
Actual Primary Completion DateApril 2008
Primary Outcome Measures

To assess the activity of ZD1839 in patients with malignant mesothelioma by estimating the objective response rate (CR and PR) at trial closure [Time Frame: Proportion of patients responding at trial closure, ITT population]

To further characterize the safety profile of ZD1839 at a 250mg daily dose [Time Frame: Proportion of patients responding at trial closure, ITT population]

Secondary Outcome Measures

To estimate PFS (progression free survival) [Time Frame: 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 [Time Frame: 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 [Time Frame: Median time from objective response to progression or death; only patients who responded are included in this analysis]

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Mesothelioma
Intervention
  • Drug: ZD1839
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment23
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria

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

Administrative Information
NCTIDNCT00787410
Responsible Party,
SponsorAstraZeneca
Verification DateJune 2012
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