Clinical trial NCT00039182: Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
Official title: A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Malignant Mesothelioma
Epithelial Mesothelioma
Recurrent Malignant Mesothelioma
Sarcomatous Mesothelioma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Overall survival rate
timeFrame: 1 year
measure: RECIST response rate
timeFrame: Up to 3 years
measure: Association between EGFR expression with survival and response
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Southwest Oncology Group
state: Texas
Study officials:
affiliation: SWOG Cancer Research Network
name: Linda Garland
role: PRINCIPAL_INVESTIGATOR
References: