An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mesothelioma
Intervention: ZD1839 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Christopher Lee, MD, Principal Investigator, Affiliation: Fraser Valley Cancer Centre Surrey Memorial Hospital, Surrey BC, Canada
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.
Clinical Details
Official title: An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To assess the activity of ZD1839 in patients with malignant mesothelioma by estimating the objective response rate (CR and PR) at trial closureTo further characterize the safety profile of ZD1839 at a 250mg daily dose
Secondary outcome: To estimate PFS (progression free survival)To estimate overall survival To estimate duration of response
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: September 2003
Last updated: June 5, 2012
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