Erlotinib Compared With Temozolomide or Carmustine in Treating Patients With Recurrent Glioblastoma Multiforme
Brain and Central Nervous System Tumors
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma
Eligibility Criteria
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
Sites / Locations
- U.Z. Gasthuisberg
- Centre de Lutte Contre le Cancer Georges-Francois Leclerc
- Centre Regional Rene Gauducheau
- Centre Antoine Lacassagne
- CHU Pitie-Salpetriere
- Institut Gustave Roussy
- Azienda Ospedaliera di Padova
- Medisch Centrum Haaglanden
- University Medical Center Rotterdam at Erasmus Medical Center
- Western Infirmary