Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung

Phase 2

Completed

• Conditions: Advanced Malignant Mesothelioma; Epithelial Mesothelioma; Recurrent Malignant Mesothelioma; Sarcomatous Mesothelioma
• Interventions: Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis

• Registration Number: NCT00039182
• Lead Sponsor: National Cancer Institute (NCI)

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-06-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2007-06
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (erlotinib hydrochloride)	erlotinib hydrochloride	Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment (erlotinib hydrochloride)	laboratory biomarker analysis	Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Overall survival rate	1 year	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.
RECIST response rate	Up to 3 years
Association between EGFR expression with survival and response	Up to 3 years

Trial Locations

Locations (1)

Southwest Oncology Group; 🇺🇸 San Antonio, Texas, United States