Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung

NCT00039182 | Completed Phase 2

• 4 other identifiers: NCI-2012-02466SWOG-S0218U10CA032102CDR0000069360
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Malignant Mesothelioma; Epithelial Mesothelioma; Recurrent Malignant Mesothelioma; Sarcomatous Mesothelioma

Outcome Measures

Primary Outcomes (3)

• 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.

  1 year

• RECIST response rate

  Up to 3 years

• Association between EGFR expression with survival and response

  Up to 3 years

Study Arms (1)

Treatment (erlotinib hydrochloride)

EXPERIMENTAL

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

Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis

Interventions

erlotinib hydrochloride DRUG

Given orally

Also known as: CP-358,774, erlotinib, OSI-774

Treatment (erlotinib hydrochloride)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (erlotinib hydrochloride)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Conditions

Mesothelioma, Malignant; Solitary Fibrous Tumor, Pleural

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Solitary Fibrous Tumors; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Linda Garland

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: June 1, 2007
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

US (1)