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
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Tracking Information | ||||
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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 |
Response rate | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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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. |
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Detailed Description | OBJECTIVES:
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
73 | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Sex/Gender ICMJE |
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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 |
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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 |
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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 |