Official Title: “A Phase II Study Of ZD 1839 (NSC 715055, IND 61187) In Patients With Malignant Mesothelioma”

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of malignant mesothelioma.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have malignant mesothelioma.

Study Type: Interventional

Study Design: Treatment

OBJECTIVES: - Determine the activity of gefitinib, in terms of failure-free survival, in patients with malignant mesothelioma. - Determine the response rate in patients treated with this drug. - Determine the toxicity of this drug in these patients. - Determine the overall survival of patients treated with this drug. - 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.

Intervention(s) in this Clinical Trial

• Drug: gefitinib

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• CTC 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other:

• 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 other concurrent uncontrolled illness
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior epidermal growth factor receptor-inhibitor therapy

Chemotherapy:

• Prior intrapleural cytotoxic or sclerosing agents (including bleomycin) allowed
• No prior systemic cytotoxic chemotherapy for malignant mesothelioma
• No concurrent chemotherapy

Endocrine therapy:

• At least 1 week since prior CYP3A4 inducers (e.g., dexamethasone, glucocorticoids, progesterone)
• No concurrent CYP3A4 inducers (e.g., dexamethasone)
• No concurrent hormonal therapy (e.g., tamoxifen) except steroids for adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes)

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy
• No concurrent radiotherapy, including for palliation

Surgery:

• See Disease Characteristics
• At least 2 weeks since prior major surgery

Other:

• At least 1 week since other prior CYP3A4 inducers (e.g., carbamazepine, ethosuximide, griseofulvin, nafcillin, nelfinavir mesylate, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rofecoxib, St. John's Wort, sulfadimidine, sulfinpyrazone, or troglitazone)
• No other concurrent CYP3A4 inducers
• No concurrent CYP3A4 substrates or inhibitors
• No other concurrent investigational agent
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent chlorpromazine, amiodarone, or chloroquine

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Cancer and Leukemia Group B

Overall Clinical Trial Officials and Contacts

Ramaswamy Govindan, MD Study Chair Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00025207

Study ID Number: CDR0000068938

ClinicalTrials.gov Identifier: NCT00025207

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database