A Phase II Study Of ZD 1839 (NSC 715055, IND 61187) In Patients With Malignant Mesothelioma

National Cancer Institute (NCI)1 site in 1 country40 target enrollmentSeptember 2001

ConditionsAdvanced Malignant Mesothelioma Epithelial Mesothelioma Recurrent Malignant Mesothelioma Sarcomatous Mesothelioma

Interventionsgefitinib laboratory biomarker analysis

Drugsgefitinib

Overview

Phase: Phase 2
Intervention: gefitinib
Conditions: Advanced Malignant Mesothelioma
Sponsor: National Cancer Institute (NCI)
Enrollment: 40
Locations: 1
Primary Endpoint: Percentage of patients who remain failure-free
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Phase II trial to study the effectiveness of gefitinib in treating patients who have malignant mesothelioma. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of malignant mesothelioma

Detailed Description

OBJECTIVES: I. Determine the activity of gefitinib, in terms of failure-free survival, in patients with malignant mesothelioma. II. Determine the response rate in patients treated with this drug. III. Determine the toxicity of this drug in these patients. IV. Determine the overall survival of patients treated with this drug. V. Determine whether overexpression of epidermal growth factor receptor and expression of cyclo-oxygenase-2 can predict the effectiveness of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral gefitinib once daily on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year and then every 6 months for up to 3 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 7-10 months.

Registry

clinicaltrials.gov

Start Date

September 2001

End Date

February 2006

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

National Cancer Institute (NCI)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed malignant mesothelioma that is not amenable to curative surgery or radiotherapy
•Epithelial, sarcomatoid, or mixed subtype
•Any site of origin (including, but not limited to, the pleura, peritoneum, pericardium, or tunica vaginalis) allowed
•Measurable disease, defined as lesions that can be accurately measured in at least 1 dimension (longest diameter) as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
•Must be outside prior radiation port
•Lesions not considered measurable include the following:
•Bone lesions
•Leptomeningeal disease
•Pleural/pericardial effusion
•Inflammatory breast disease

Exclusion Criteria

Not provided

Arms & Interventions

Treatment (gefitinib)

Patients receive oral gefitinib once daily on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Intervention: gefitinib

Treatment (gefitinib)

Patients receive oral gefitinib once daily on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Intervention: laboratory biomarker analysis

Outcomes

Primary Outcomes

Percentage of patients who remain failure-free

Time Frame: Time between the initiation of treatment and initial failure (disease progression, relapse, death), assessed up to 3 months

Kaplan-Meier's product limit estimator and curves will be used.

Secondary Outcomes

Toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0(Up to 4 years)
Failure-free survival within patient subgroups defined in terms of epidermal growth factor receptor (EGFR) overexpression and cyclooxygenase-2 (COX-2) expression(Up to 4 years)
Overall survival(Up to 4 years)
Tumor response rate(Up to 4 years)