Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung

• ClinicalTrials.gov Identifier: NCT00039182
• Recruitment Status: Completed
• First Posted: January 27, 2003
• Last Update Posted: January 24, 2013
• Sponsor: National Cancer Institute (NCI)
• Information provided by (Responsible Party): National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: June 6, 2002
• First Posted Date: January 27, 2003
• Last Update Posted Date: January 24, 2013
• Study Start Date: May 2002
• Actual Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 23, 2013)

• Overall survival rate [ Time Frame: 1 year ]
  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 ]
• Association between EGFR expression with survival and response [ Time Frame: Up to 3 years ]

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• Drug: erlotinib hydrochloride
  Given orally
  Other Names:

  • CP-358,774
  • erlotinib
  • OSI-774
• Other: laboratory biomarker analysis
  Correlative studies

Study Arms

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.

Interventions:

• Drug: erlotinib hydrochloride
• Other: laboratory biomarker analysis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 23, 2013): 55
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Actual Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00039182
• Other Study ID Numbers: NCI-2012-02466; SWOG-S0218; U10CA032102 ( U.S. NIH Grant/Contract ); CDR0000069360 ( Registry Identifier: PDQ (Physician Data Query) )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: National Cancer Institute (NCI)
• Original Responsible Party: Not Provided
• Current Study Sponsor: National Cancer Institute (NCI)
• Original Study Sponsor: Southwest Oncology Group
• Collaborators: Not Provided

Investigators

• Principal Investigator: Linda Garland; Southwest Oncology Group

• PRS Account: National Cancer Institute (NCI)
• Verification Date: January 2013