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Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
This study has been completed.
First Received: June 6, 2002   Last Updated: January 28, 2009   History of Changes
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00039182
  Purpose

RATIONALE: Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with malignant mesothelioma of the lung.


Condition Intervention Phase
Malignant Mesothelioma
Drug: erlotinib hydrochloride
Phase II

MedlinePlus related topics: Cancer Mesothelioma
Drug Information available for: Erlotinib hydrochloride Erlotinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma

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

Study Start Date: May 2002
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the 1-year survival rate in patients with unresectable malignant pleural mesothelioma treated with erlotinib.
  • Determine the response rate in patients with measurable disease treated with this drug.
  • Determine the frequency and severity of toxic effects of this drug in these patients.
  • 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

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant pleural mesothelioma

    • Epithelial
    • Sarcomatous
    • Biphasic
  • Measurable or nonmeasurable disease
  • Not amenable to extrapleural pneumonectomy
  • No known CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • 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)

Renal:

  • Creatinine no greater than 2 times ULN

Gastrointestinal:

  • 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

Ophthalmic:

  • 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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy for this tumor

Chemotherapy:

  • No prior chemotherapy for this tumor

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered

Surgery:

  • 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

Other:

  • No prior investigational anticancer agents for this tumor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039182

  Show 101 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Linda Garland, MD University of Arizona
  More Information

Additional Information:
Publications:
Garland LL, Rankin C, Gandara DR, Rivkin SE, Scott KM, Nagle RB, Klein-Szanto AJ, Testa JR, Altomare DA, Borden EC. Phase II study of erlotinib in patients with malignant pleural mesothelioma: a Southwest Oncology Group Study. J Clin Oncol. 2007 Jun 10;25(17):2406-13.
Garland L, Rankin C, Scott K, et al.: Molecular correlates of the EGFR signaling pathway in association with SWOG S0218: a phase II study of oral EGFR tyrosine kinase inhibitor OSI-774 (NSC-718781) in patients with malignant pleural mesothelioma (MPM). [Abstract] J Clin Oncol 22 (Suppl 14): A-3007, 196s, 2004.

Study ID Numbers: CDR0000069360, SWOG-S0218
Study First Received: June 6, 2002
Last Updated: January 28, 2009
ClinicalTrials.gov Identifier: NCT00039182     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma
recurrent malignant mesothelioma
epithelial mesothelioma
sarcomatous mesothelioma

Study placed in the following topic categories:
Erlotinib
Mesothelioma
Protein Kinase Inhibitors
Adenoma
Recurrence
Neoplasms, Glandular and Epithelial

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

ClinicalTrials.gov processed this record on May 07, 2009