Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00039182
First received: June 6, 2002
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Advanced Malignant Mesothelioma
Epithelial Mesothelioma
Recurrent Malignant Mesothelioma
Sarcomatous Mesothelioma
Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Association between EGFR expression with survival and response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: May 2002
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (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.
Drug: erlotinib hydrochloride
Given orally
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039182

Locations
United States, Texas
Southwest Oncology Group
San Antonio, Texas, United States, 78245
Sponsors and Collaborators
Investigators
Principal Investigator: Linda Garland Southwest Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00039182     History of Changes
Other Study ID Numbers: NCI-2012-02466, SWOG-S0218, U10CA032102, CDR0000069360
Study First Received: June 6, 2002
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014