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

Phase 2
Not Enrolling
Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatous Mesothelioma

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Trial Information

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


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

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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Overall survival rate

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Linda Garland

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

May 2002

Completion Date:

Related Keywords:

  • Advanced Malignant Mesothelioma
  • Epithelial Mesothelioma
  • Recurrent Malignant Mesothelioma
  • Sarcomatous Mesothelioma
  • Mesothelioma



Southwest Oncology Group San Antonio, Texas  78245