Clinical Trial: Oral Tarceva Study for Recurrent/Residual Glioblastoma Multiforme and Anaplastic Astrocytoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase I/II Trial of Oral Erlotinib (Tarceva, OSI-774) for Treatment of Relapsed/Refractory Glioblastoma Multiforme and Anaplastic Astrocytoma

Brief Summary: This study will offer a safe treatment for patients with relapsing recurring glioblastoma (GBM) or anaplastic astrocytoma (AA). The trial will test the hypothesis that Erlotinib (Tarceva, OSI-774) can be safely used up to a dose of 150 mg two times a day for 12 months to ultimately enhance survival of patients with relapsed/refractory GBM/AA. Correlation of response to Tarceva with particular genetic alterations including epidermal growth factor receptor variant type III (EGFRvIII) amplification and phosphatase and tensin homolog (mutated in multiple advanced cancers 1) (PTEN) loss will be studied.

Detailed Summary: The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of tumors also exhibits the most aggressive behavior, resulting in median overall survival durations of only 9-12 months for GBM, and 3-4 years for AA, from initial diagnosis, despite multimodal treatment approaches. Initial therapy consists of either surgical resection, external beam radiation or both. The role of adjuvant or concomitant chemotherapy in the initial therapy of GBM and AA has not, as yet, been clearly defined. Since most of these patients experience a recurrence after first-line therapy, improvements in both first-line and salvage therapy are critical to enhancing quality-of-life and prolonging survival. In August 2003, the U.S. Food and Drug Administration (FDA) granted orphan drug status for Erlotinib in patients with malignant glioma. Erlotinib (OSI-774) has been shown to be active in a range of tumors including GBM, AA and non small cell lung cancer. Because of the promising results in preliminary studies of Erlotinib and because of significant experience with the safety of the dosages proposed in this study, this study will offer a safe adjuvant treatment for patients with relapsing recurring glioblastoma or anaplastic astrocytoma. Therefore, this phase I/II clinical research trial will test the hypothesis that Erlotinib can be safely used up to a dose of 150 mg bid for 12 cycles to ultimately enhance survival of patients with relapsed/refractory GBM/AA with particular genetic alterations including EGFRvIII amplification and PTEN loss.
Sponsor: Northwell Health

Current Primary Outcome: Safety of Twice a Day Oral 150 mg Erlotinib Dosing [ Time Frame: duration of the trial ]

Greater than or equal to Grade 2 Adverse Event


Original Primary Outcome: Safety of Twice a Day Oral 150 mg Erlotinib Dosing

Current Secondary Outcome:

  • 6-month Progression Free Survival (PFS) [ Time Frame: Duration of the trial ]
  • Overall Survival (OS) [ Time Frame: Duration of the trial ]


Original Secondary Outcome:

  • Composite overall response rate (CORR)
  • 6-month Progression Free Survival (PFS)
  • Overall Survival (OS)


Information By: Northwell Health

Dates:
Date Received: March 9, 2006
Date Started: March 2006
Date Completion:
Last Updated: January 12, 2016
Last Verified: January 2016