S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
Condition: Sarcoma
MeSH terms: Sarcoma; Nerve Sheath Neoplasms; Neurofibrosarcoma
Intervention: erlotinib hydrochloride
Intervention description: 150 mg per day, daily until disease progression
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
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

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.
    

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