Clinical Trial: Erlotinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase-2 Study of Tarceva in Patients With Recurrent EGFR Positive and Phosphatase and Tensin Homolog (PTEN) Wild Type Glioblastoma Multiforme and Gliosarcoma

Brief Summary:

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with recurrent glioblastoma multiforme or gliosarcoma.


Detailed Summary:

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with recurrent epidermal growth factor receptor (EGFR)-positive and PTEN wild-type glioblastoma multiforme or gliosarcoma treated with erlotinib hydrochloride.

Secondary

  • Assess the response rate in patients who also EGFRVIII mutant and PTEN wild type glioblastoma multiforme or gliosarcoma.
  • Determine the progression-free survival of patients treated with this drug.

OUTLINE: This is an open-label study. Patients are stratified according to concurrent use of enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no).

Patients receive oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Some patients may receive additional erlotinib hydrochloride after 1 year at their physician's discretion.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.


Sponsor: Michael Prados

Current Primary Outcome: Disease Response Measured Objectively by MRI of Brain [ Time Frame: Every 8 weeks or as indicated ]

Lack of disease progression indicates response to treatment


Original Primary Outcome:

Current Secondary Outcome: Duration of Progress-free Survival (PFS) [ Time Frame: Until first observation of progressive disease, non-reversible neurologic progression or permanently increased steroid requirement (stable disease only), death due to any cause (up to 16 weeks) ]

Patients with stable or responding disease will continue treatment until tumor progression is determined


Original Secondary Outcome:

Information By: University of California, San Francisco

Dates:
Date Received: October 12, 2006
Date Started: January 2007
Date Completion:
Last Updated: May 25, 2013
Last Verified: April 2013