Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054496
First received: February 5, 2003
Last updated: January 9, 2014
Last verified: December 2006
  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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: erlotinib hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling [ Designated as safety issue: No ]
  • Efficacy of tumor EGFR amplification in predicting response to treatment [ Designated as safety issue: No ]

Estimated Enrollment: 73
Study Start Date: August 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054496

Locations
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
Investigators
Study Chair: Michael A. Vogelbaum, MD, PhD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00054496     History of Changes
Other Study ID Numbers: CDR0000270723, CCF-IRB-5478
Study First Received: February 5, 2003
Last Updated: January 9, 2014
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult glioblastoma
recurrent adult brain tumor
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014