Conditions: Sarcoma
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
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 24
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Drug: erlotinib hydrochloride

Other Names:

OSI-774 150 mg per day, daily until disease progression

Interventions: intervention 1: erlotinib hydrochloride
Intervention descriptions: intervention 1: 150 mg per day, daily until disease progression

Protocol document: