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Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

Phase 2
Conditions
Brain and Central Nervous System Tumors
Registration Number
NCT00054496
Lead Sponsor
The Cleveland Clinic
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
73
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Response rate
Secondary Outcome Measures
NameTimeMethod
Overall survival
Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling
Efficacy of tumor EGFR amplification in predicting response to treatment
Progression-free survival

Trial Locations

Locations (1)

Cleveland Clinic Taussig Cancer Center

🇺🇸

Cleveland, Ohio, United States

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