Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Gefitinib in Treating Patients With Malignant Mesothelioma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Over 18	NCI	CLB-30101 NCT00025207, CALGB-30101

Objectives

1. Determine the activity of gefitinib, in terms of failure-free survival, in patients with malignant mesothelioma.
2. Determine the response rate in patients treated with this drug.
3. Determine the toxicity of this drug in these patients.
4. Determine the overall survival of patients treated with this drug.
5. Determine whether overexpression of epidermal growth factor receptor and expression of cyclo-oxygenase-2 can predict the effectiveness of this drug in these patients.

Entry Criteria

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

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

Patient Characteristics:

Age:

• Over 18

Performance status:

• CTC 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 40 patients will be accrued for this study within 7-10 months.

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.

Govindan R, Kratzke RA, Herndon JE 2nd, et al.: Gefitinib in patients with malignant mesothelioma: a phase II study by the Cancer and Leukemia Group B. Clin Cancer Res 11 (6): 2300-4, 2005.[PUBMED Abstract]

Govindan R, Kratzke RA, Herndon JE, et al.: Gefitinib in patients with malignant mesothelioma (MM): a phase II study by the Cancer and Leukemia Group B (CALGB 30101). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2535, 630, 2003.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Ramaswamy Govindan, MD, Protocol chair		Ph: 314-362-4819; 800-600-3606

Registry Information
Official Title		A Phase II Study Of ZD 1839 (NSC 715055, IND 61187) In Patients With Malignant Mesothelioma
Trial Start Date		2001-08-15
Registered in ClinicalTrials.gov		NCT00025207
Date Submitted to PDQ		2001-08-06
Information Last Verified		2006-09-26
NCI Grant/Contract Number		CA31946

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