Brain and Central Nervous System Tumors
Conditions
Keywords
adult glioblastoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma
Brief 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.
Interventions
DRUGerlotinib hydrochloride
Sponsors
The Cleveland Clinic
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
| Overall survival | — |
| Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling | — |
| Efficacy of tumor EGFR amplification in predicting response to treatment | — |
Countries
United States
Outcome results
None listed