Mesothelioma
Conditions
Keywords
malignant mesothelioma, IRESSA, ZD1839
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.
Interventions
DRUGZD1839
250mg tablet, once daily, orally administered
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Outcome results
None listed