s0330 erlotinib in treating patients with unresectable or metastatic malignant peripheral nerve sheath tumor

Conditions: Sarcoma

Summary: 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.

Eligibility criteria:
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

Keywords: 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