Gefitinib in Treating Patients With Malignant Mesothelioma (NCT00025207) | Clinical Trial Compass
CompletedPhase 2
Gefitinib in Treating Patients With Malignant Mesothelioma
United States40 participantsStarted 2001-09
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Ascites
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Abdominal masses not confirmed and followed by imaging techniques
* Cystic lesions
* No known brain metastases
* Performance status - CTC 0-1
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 2.5 times ULN
* Creatinine no greater than 1.5 times ULN
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other concurrent active malignancy except nonmelanoma skin cancer
* Disease considered not currently active if completely treated with less than a 30% risk for relapse
* No …
What they're measuring
1
Percentage of patients who remain failure-free
Timeframe: Time between the initiation of treatment and initial failure (disease progression, relapse, death), assessed up to 3 months