Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: erlotinib hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: erlotinib hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult glioblastoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma