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Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung

Primary Purpose

Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Recurrent Malignant Mesothelioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
erlotinib hydrochloride
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Malignant Mesothelioma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (erlotinib hydrochloride)

Arm Description

Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Overall survival rate
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
Association between EGFR expression with survival and response

Secondary Outcome Measures

Full Information

First Posted
June 6, 2002
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00039182
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatous Mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (erlotinib hydrochloride)
Arm Type
Experimental
Arm Description
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Other Intervention Name(s)
CP-358,774, erlotinib, OSI-774
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Overall survival rate
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.
Time Frame
1 year
Title
RECIST response rate
Time Frame
Up to 3 years
Title
Association between EGFR expression with survival and response
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Garland
Organizational Affiliation
SWOG Cancer Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Oncology Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78245
Country
United States

12. IPD Sharing Statement

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Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung

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