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Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054496
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : February 6, 2003
Last Update Posted : January 10, 2014
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: erlotinib hydrochloride Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme
Study Start Date : August 2002

Primary Outcome Measures :
  1. Response rate

Secondary Outcome Measures :
  1. Progression-free survival
  2. Overall survival
  3. Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling
  4. Efficacy of tumor EGFR amplification in predicting response to treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2 times normal
  • Alkaline phosphatase no greater than 2 times normal
  • ALT no greater than 3 times normal


  • BUN no greater than 1.5 times normal OR
  • Creatinine no greater than 1.5 times normal


  • 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


Biologic therapy

  • No concurrent immunotherapy for brain cancer
  • No concurrent biologic therapy for brain cancer


  • 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


  • See Disease Characteristics


  • Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00054496

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United States, Ohio
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente    866-223-8100      
Sponsors and Collaborators
The Cleveland Clinic
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Study Chair: Michael A. Vogelbaum, MD, PhD The Cleveland Clinic
Layout table for additonal information Identifier: NCT00054496    
Other Study ID Numbers: CDR0000270723
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: December 2006
Keywords provided by National Cancer Institute (NCI):
adult glioblastoma
recurrent adult brain tumor
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action