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Status:

COMPLETED

Erlotinib Compared With Temozolomide or Carmustine in Treating Patients With Recurrent Glioblastoma Multiforme

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide and carmustine, work in different ways to s...

Detailed Description

OBJECTIVES: Primary * Compare the therapeutic activity of erlotinib vs temozolomide or carmustine in patients with recurrent glioblastoma multiforme. * Compare 6-month progression-free survival in p...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2011

    Estimated Enrollment :

    110 Patients enrolled

    Trial Details

    Trial ID

    NCT00086879

    Start Date

    May 1 2004

    End Date

    March 1 2011

    Last Update

    July 27 2017

    Active Locations (10)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (10 locations)

    1

    U.Z. Gasthuisberg

    Leuven, Belgium, B-3000

    2

    Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, France, 21079

    3

    Centre Regional Rene Gauducheau

    Nantes-Saint Herblain, France, 44805

    4

    Centre Antoine Lacassagne

    Nice, France, 06189