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Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
This study has been completed.
Study NCT00039182   Information provided by National Cancer Institute (NCI)
First Received: June 6, 2002   Last Updated: January 28, 2009   History of Changes

June 6, 2002
January 28, 2009
May 2002
June 2007   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00039182 on ClinicalTrials.gov Archive Site
 
 
 
Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma

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.

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.

Phase II
Interventional
Treatment
Malignant Mesothelioma
Drug: erlotinib hydrochloride
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
June 2007   (final data collection date for primary outcome measure)

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00039182
 
CDR0000069360, SWOG-S0218
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Linda Garland, MD University of Arizona
National Cancer Institute (NCI)
April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP