Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

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

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.

Eligibility: 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

Relevance to patient case: not relevant