S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II|
- Tumor response as assessed by RECIST radiographic criteria [ Time Frame: every eight weeks during treatment ] [ Designated as safety issue: No ]x-rays and scans
- Toxicity as assessed by CTCAE [ Time Frame: every two weeks for two cycles and then every four weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2003|
|Study Completion Date:||August 2009|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Drug: erlotinib hydrochloride
- 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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|Study Chair:||Karen H. Albritton, MD||Dana-Farber Cancer Institute|
|Study Chair:||R. Lor Randall, MD, FACS||University of Utah|
|Study Chair:||Scott M. Schuetze, MD, PhD||University of Michigan Cancer Center|