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Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE February 5, 2003
First Posted Date  ICMJE February 6, 2003
Last Update Posted Date January 10, 2014
Study Start Date  ICMJE August 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Response rate
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00054496 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme
Official Title  ICMJE Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE Drug: erlotinib hydrochloride
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
73
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00054496
Other Study ID Numbers  ICMJE CDR0000270723
CCF-IRB-5478
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Michael A. Vogelbaum, MD, PhD The Cleveland Clinic
PRS Account National Cancer Institute (NCI)
Verification Date December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP