S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068367
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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|