S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: erlotinib hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignant peripheral nerve sheath tumor Malignant schwannoma or neurofibrosarcoma Clinical evidence of unresectable or metastatic disease Measurable disease No known current CNS metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT or SGPT less than 1.5 times ULN (5 times ULN for patients with documented liver metastases) Renal Creatinine no greater than 1.5 times ULN Creatinine clearance greater than 60 mL/min Ophthalmic No known history of any of the following corneal diseases: Dry eye syndrome Sjögren's syndrome Keratoconjunctivitis sicca Exposure keratopathy Fuch's dystrophy No other active disorders of the cornea Gastrointestinal No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation No active peptic ulcer disease No intractable nausea or vomiting Able to swallow medications OR receive enteral medications via gastrostomy feeding tube Other Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy More than 28 days since prior biologic therapy for this malignancy Chemotherapy More than 28 days since prior chemotherapy for this malignancy Endocrine therapy Not specified Radiotherapy More than 60 days since prior radiotherapy to the target lesion with subsequent documented progression More than 60 days since prior radiofrequency ablation to the target lesion with subsequent documented progression No concurrent radiotherapy Surgery At least 3 weeks since prior major surgery and recovered No prior surgical procedure affecting absorption Other More than 28 days since prior investigational drugs for this malignancy More than 60 days since prior embolization to the target lesion with subsequent documented progression No prior epidermal growth factor receptor-targeting therapy No concurrent antiretroviral therapy for HIV-positive patients No other concurrent investigational or commercial agents or therapies for the malignancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (OSI-774)<br>Drug: erlotinib hydrochloride Other Names: OSI-774 150 mg per day, daily until disease progression | Drug: erlotinib hydrochloride<br>* 150 mg per day, daily until disease progression<br>* Other names: OSI-774;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib. | 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. | 25 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity | Only adverse events that are possibly, probably or definitely related to study drug are reported. | Up to 25 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult neurofibrosarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage IV adult soft tissue sarcoma