SWOG clinical trial number
S0218

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

Closed
Phase
Accrual
100%
Published
Abbreviated Title
Malignant Pleural Mesothelioma
Activated
05/01/2002
Closed
04/01/2003
Participants
NCORP, Members, Medical Oncologists

Research committees

Sarcoma
Lung Cancer

Treatment

Erlotinib

Eligibility Criteria Expand/Collapse

Pts must have histologically confirmed dx of unresectable malignant pleural mesothelioma and histologically confirmed dx of epithelial sarcomatous or biphasic mesothelioma not amendable to extrapleural pneumonectomy. Pts must have measurable or non-measurable dz by CT or MRI examination that must be assessed w/in 28 days of registration. Pts must have available and must be willing to submit archived tumor tissue that will yield sixteen 5-micron slides for correlative studies. No prior chemo, biologic therapy, or investigational anti-ca agents for any reason for this tumor. Prior srg allowed but at least 4 weeks must have elapsed and pt must have recovered from all side effects associated. Prior RT allowed provided at least 3 weeks elapsed since the last tx and pt must have recovered from all associated tx at the time of registration. Zubrod PS 0-1. Pts w/ known h/o dry eye syndrome, Sjogren's syndrome, keratoconjunctivitis sicca, exposure to keratopathy, Fuch's dystrophy or other active disorders of the cornea are not eligible. Pts must not be known to be HIV postive and receiving combination anti-retroviral therapy; no known CNS mets; must not be pregnant or nursing; and pts must not have GI tract dz resulting in an inability to take oral med or a requirement for IV alimentation, prior srg procedures affecting absorption, or active peptic ulcer dz. Pts must be able to swallow and/or receive enteral med via gastrostomy feeding tube. Pts w/ intractable nausea or vomiting are not eligible.

Publication Information Expand/Collapse

2007

A phase II study of erlotinib in patients with malignant pleural mesothelioma: a Southwest Oncology Group study [PMID17557954]

LL Garland;CJ Rankin;DR Gandara;SE Rivkin;KM Scott;RB Nagle;A Klein-Szanto;JR Testa;DA Altomare;EC Borden Journal of Clinical Oncology 25(17):2406-2413

2004

Molecular correlates of the EGFR signaling pathway in association with SWOG S0218: a phase II study of oral EGFR tyrosine kinase inhibitor OSI-774 (NSC-718781) in patients with malignant pleural mesothelioma (MPM)

L Garland;C Rankin;K Scott;R Nagle;M Lobell;D Gandara;S Rivkin;W Samlowski;J Atkins;E Borden Proc of the American Society of Clincial Oncology 23:196 (#3007)