Back to resultsAn Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
Primary Purpose
Mesothelioma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ZD1839
Sponsored by
About this trial
This is an interventional treatment trial for Mesothelioma focused on measuring malignant mesothelioma, IRESSA, ZD1839
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
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
To further characterize the safety profile of ZD1839 at a 250mg daily dose
Secondary Outcome Measures
To estimate PFS (progression free survival)
To estimate overall survival
To estimate duration of response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00787410
Brief Title
An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
Official Title
An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma
Keywords
malignant mesothelioma, IRESSA, ZD1839
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ZD1839
Other Intervention Name(s)
IRESSA
Intervention Description
250mg tablet, once daily, orally administered
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Lee, MD
Organizational Affiliation
Fraser Valley Cancer Centre Surrey Memorial Hospital, Surrey BC, Canada
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
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