Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Epithelial Mesothelioma

Advanced Malignant Mesothelioma

Recurrent Malignant Mesothelioma

Sarcomatous Mesothelioma

Treatments

Drug: erlotinib hydrochloride

Other: laboratory biomarker analysis

Study type

Interventional

Funder types

NIH

Identifiers

NCT00039182

SWOG-S0218

CDR0000069360 (Registry Identifier)

NCI-2012-02466

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. This phase II trial is studying how well erlotinib works in treating patients with malignant mesothelioma of the lung

Full description

PRIMARY OBJECTIVES:

I. Determine the 1-year survival rate in patients with unresectable malignant pleural mesothelioma treated with erlotinib.

II. Determine the response rate in patients with measurable disease treated with this drug.

III. Determine the frequency and severity of toxic effects of this drug in these patients.

IV. Measure epidermal growth factor receptor (EGFR) expression, EGFR gene amplification, and other activation products in the EGFR signaling pathway in tumor samples and correlate with clinical outcomes in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 2 years and then annually for 1 year.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14-18 months.

Enrollment

55 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Histologically confirmed malignant pleural mesothelioma
- Epithelial
- Sarcomatous
- Biphasic
Measurable or nonmeasurable disease
Not amenable to extrapleural pneumonectomy
No known CNS metastases
Performance status - Zubrod 0-1
WBC at least 3,000/mm^3
Absolute neutrophil 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 or SGPT no greater than 1.5 times ULN (5 times ULN if liver involvement of tumor)
Creatinine no greater than 2 times ULN
No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
No active peptic ulcer disease
No intractable nausea or vomiting
Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube
No known history of the following:
- Dry eye syndrome
- Sjogren's syndrome
- Keratoconjunctivitis sicca
- Exposure keratopathy
- Fuch's dystrophy
- Other active disorders of the cornea
Not pregnant or nursing
Fertile patients must use effective contraception
No HIV-positive patients receiving combination antiretroviral therapy
No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer that is in complete remission
No prior biologic therapy for this tumor
No prior chemotherapy for this tumor
See Disease Characteristics
At least 3 weeks since prior radiotherapy and recovered
See Disease Characteristics
At least 4 weeks since prior major surgery (e.g., thoracotomy or laparotomy), excluding minor surgeries (e.g., mediastinoscopy, thoracoscopy, or minor biopsies)
Recovered from prior surgery
No prior surgical procedures affecting absorption
No prior investigational anticancer agents for this tumor