Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung

Recurrent Malignant Mesothelioma Clinical Trial

Official title:

A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039182
• Other study ID #: NCI-2012-02466
• Secondary ID: SWOG-S0218U10CA0
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2002
• Last updated: January 23, 2013
• Start date: May 2002

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Malignant Mesothelioma
• Epithelial Mesothelioma
• Lung Neoplasms
• Mesothelioma
• Recurrent Malignant Mesothelioma
• Sarcomatous Mesothelioma

Intervention

Drug:
• erlotinib hydrochloride
Given orally

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Southwest Oncology Group	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate	Erlotinib hydrochloride will not be of further interest if the true one-year survival rate is 35% or less, but of considerable interest if 55% or more.	1 year	No
Primary	RECIST response rate		Up to 3 years	No
Primary	Association between EGFR expression with survival and response		Up to 3 years	No