Clinical Trials /

Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

NCT00054496

Description:

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.

Related Conditions:
  • Conventional Glioblastoma Multiforme
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme
  • Official Title: Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme

Clinical Trial IDs

  • ORG STUDY ID: CDR0000270723
  • SECONDARY ID: CCF-IRB-5478
  • NCT ID: NCT00054496

Conditions

  • Brain and Central Nervous System Tumors

Interventions

DrugSynonymsArms
erlotinib hydrochloride

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Response rate
Time Frame:
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression-free survival
Time Frame:
Safety Issue:
Description:
Measure:Overall survival
Time Frame:
Safety Issue:
Description:
Measure:Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling
Time Frame:
Safety Issue:
Description:
Measure:Efficacy of tumor EGFR amplification in predicting response to treatment
Time Frame:
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:The Cleveland Clinic

Trial Keywords

  • adult glioblastoma
  • recurrent adult brain tumor
  • adult giant cell glioblastoma
  • adult gliosarcoma

Last Updated

January 9, 2014