Erlotinib Compared With Temozolomide or Carmustine in Treating Patients With Recurrent Glioblastoma Multiforme

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed glioblastoma multiforme
• * Some oligodendroglial elements allowed provided they make up \< 25% of the tumor
• Recurrent disease documented by MRI after prior radiotherapy
• At least 1 bidimensionally measurable target lesion ≥ 2 cm by MRI
• Undergone prior surgery for recurrent primary brain tumor more than 3 months before study entry
• * Must have a clearly limited target lesion ≥ 2 cm OR evidence of progressive and measurable target lesion OR a second measurable target lesion outside the surgical area
• PATIENT CHARACTERISTICS:
• Age
• Over 18
• Performance status
• Karnofsky 70-100%
• Life expectancy
• Not specified
• Hematopoietic
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm \^3
• Hepatic
• AST and ALT \< 2.5 times upper limit of normal (ULN)
• Bilirubin \< 1.5 times ULN
• Renal
• Creatinine \< 1.5 times ULN
• Cardiovascular
• Clinically normal cardiac function
• No ischemic heart disease within the past 12 months
• No New York Heart Association grade III or IV cardiac insufficiency
• No unstable angina
• No arryhthmia
• Pulmonary
• DLCO \> 70% of predicted (for patients randomized to receive erlotinib \[arm I\] or carmustine \[arm II\])
• No history of pulmonary disease that would affect pulmonary function including any of the following:
• * Chronic bronchopneumopathy
• * Pleural effusion
• * Interstitial pnuemonia
• * Pulmonary lymphangitis
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study participation
• No other malignancy except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer
• No psychological, familial, sociological, or geographical factors that would preclude study compliance
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No prior HER-targeted agents
• No concurrent growth factors for neutrophil count elevation
• No concurrent epoetin alfa
• Chemotherapy
• Prior adjuvant temozolomide allowed
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
• No more than 1 prior adjuvant chemotherapy regimen
• No prior chemotherapy for recurrent disease
• Endocrine therapy
• Must be on a stable or decreasing dose of corticosteroids for at least 2 weeks before study entry
• Radiotherapy
• See Disease Characteristics
• More than 3 months since prior radiotherapy to the brain
• No prior high-dose radiotherapy (\> 65 Gy), stereotactic radiosurgery, or internal radiotherapy unless disease recurrence confirmed
• Surgery
• See Disease Characteristics
• Other
• No prior participation in experimental therapies
• No concurrent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, troleandomycin, cimetidine, or grapefruit juice)
• No concurrent warfarin or other coumarin derivatives
• * Concurrent low-molecular weight heparin allowed
• No other concurrent investigational drugs