S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
|ClinicalTrials.gov Identifier: NCT00068367|
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: erlotinib hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II|
|Study Start Date :||December 2003|
|Primary Completion Date :||July 2007|
|Study Completion Date :||August 2009|
Experimental: Arm I (OSI-774)
Drug: erlotinib hydrochloride
OSI-774 150 mg per day, daily until disease progression
Drug: erlotinib hydrochloride
150 mg per day, daily until disease progression
Other Name: OSI-774
- Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib. [ Time Frame: 25 weeks ]
Complete response - Complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values.
Partial response - Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease, no new lesions.
- Toxicity [ Time Frame: Up to 25 weeks ]Only adverse events that are possibly, probably or definitely related to study drug are reported.
- Correlate, Preliminarily, Indicators of Epidermal Growth Factor Receptor (EGFR) Function With Response and Progression-free and Overall Survival in Patients Treated With This Drug.NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY
- Feasibility of Accruing These Patients in the Cooperative Group SettingNOT COMPLETED DUE TO EARLY CLOSURE OF STUDY
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068367
Show 101 Study Locations
|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|