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 ]
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) ]
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