- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00054496
Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme
Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic Taussig Cancer Center
-
Contact:
- Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente
- Phone Number: 866-223-8100
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme
Radiographic evidence of recurrence or progression
- Biopsies to confirm tumor recurrence allowed if a sufficent percentage of cases are confirmed to be recurrent tumor
- Previously treated with optimal radiotherapy and at least 1 cytotoxic chemotherapy regimen
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2 times normal
- Alkaline phosphatase no greater than 2 times normal
- ALT no greater than 3 times normal
Renal
- BUN no greater than 1.5 times normal OR
- Creatinine no greater than 1.5 times normal
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No medical condition that would interfere with oral administration of erlotinib
- No other medical or psychiatric illness that would preclude study therapy
- No active infection
- No other malignancy within the past 3 years except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy for brain cancer
- No concurrent biologic therapy for brain cancer
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent chemotherapy for brain cancer
Endocrine therapy
- Concurrent glucocorticosteroids allowed
- No concurrent hormonal therapy for brain cancer
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Other
- No prior epidermal growth factor receptor (EGFR) inhibitor
- No concurrent EGFR inhibitor
- No other concurrent antineoplastic therapy
No concurrent anti-epileptic agents other than modest- or non-enzyme-inducing drugs such as the following:
- Gabapentin
- Lamotrigine
- Divalproex
- Felbamate
- Levetiracetam
- Tiagabine
- Topiramate
- Zonisamide
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Response rate
|
Secondary Outcome Measures
Outcome Measure |
---|
Progression-free survival
|
Overall survival
|
Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling
|
Efficacy of tumor EGFR amplification in predicting response to treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Michael A. Vogelbaum, MD, PhD, The Cleveland Clinic
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
Other Study ID Numbers
- CDR0000270723
- CCF-IRB-5478
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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