Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

Summary: RATIONALE: Erlotinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
  PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or progressive glioblastoma multiforme.

Detailed description: OBJECTIVES:
  -  Determine the response rate of patients with recurrent or progressive glioblastoma multiforme treated with erlotinib.
  -  Determine the progression-free and overall survival of patients treated with this drug.
  OUTLINE: Patients receive oral erlotinib daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
  Patients are followed for survival.
  PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed glioblastoma multiforme
  -  Radiographic evidence of recurrence or progression
  -  Biopsies to confirm tumor recurrence allowed if a sufficent percentage of cases are confirmed to be recurrent tumor
  -  Previously treated with optimal radiotherapy and at least 1 cytotoxic chemotherapy regimen
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Performance status
  -  Not specified
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Absolute neutrophil count at least 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic
  -  Bilirubin no greater than 2 times normal
  -  Alkaline phosphatase no greater than 2 times normal
  -  ALT no greater than 3 times normal
  Renal
  -  BUN no greater than 1.5 times normal OR
  -  Creatinine no greater than 1.5 times normal
  Other
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No medical condition that would interfere with oral administration of erlotinib
  -  No other medical or psychiatric illness that would preclude study therapy
  -  No active infection
  -  No other malignancy within the past 3 years except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  No concurrent immunotherapy for brain cancer
  -  No concurrent biologic therapy for brain cancer
  Chemotherapy
  -  See Disease Characteristics
  -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
  -  No concurrent chemotherapy for brain cancer
  Endocrine therapy
  -  Concurrent glucocorticosteroids allowed
  -  No concurrent hormonal therapy for brain cancer
  Radiotherapy
  -  See Disease Characteristics
  Surgery
  -  Not specified
  Other
  -  No prior epidermal growth factor receptor (EGFR) inhibitor
  -  No concurrent EGFR inhibitor
  -  No other concurrent antineoplastic therapy
  -  No concurrent anti-epileptic agents other than modest- or non-enzyme-inducing drugs such as the following:
  -  Gabapentin
  -  Lamotrigine
  -  Divalproex
  -  Felbamate
  -  Levetiracetam
  -  Tiagabine
  -  Topiramate
  -  Zonisamide

Relevance to patient case: not relevant