Sarcoma Clinical Trial
Official title:
U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for
tumor cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with
unresectable or metastatic malignant peripheral nerve sheath tumor.
OBJECTIVES:
- Determine response (confirmed, complete, and partial) in patients with unresectable or
metastatic malignant peripheral nerve sheath tumor when treated with erlotinib.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Correlate, preliminarily, indicators of epidermal growth factor receptor (EGFR) function
(e.g., expression, phosphorylation, or markers of signal transduction downstream of
EGFR) with response and progression-free and overall survival in patients treated with
this drug.
- Determine the feasibility of accruing these patients in the cooperative group setting.
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 who achieve at least a confirmed partial response and become resectable undergo
surgical resection (with or without radiotherapy) and then receive 2 additional courses of
erlotinib. Patients with responding disease who do not become resectable continue erlotinib
as above. Patients achieving a complete response (CR) receive 2 additional courses of
erlotinib beyond the CR.
Patients are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
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