Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
The Cleveland Clinic
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054496
First received: February 5, 2003
Last updated: July 23, 2008
Last verified: December 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: erlotinib hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Response rate [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling [ Designated as safety issue: No ]
- Efficacy of tumor EGFR amplification in predicting response to treatment [ Designated as safety issue: No ]
| Estimated Enrollment: | 73 |
| Study Start Date: | August 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054496
Locations
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
Sponsors and Collaborators
The Cleveland Clinic
Investigators
| Study Chair: | Michael A. Vogelbaum, MD, PhD | The Cleveland Clinic |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00054496 History of Changes |
| Other Study ID Numbers: | CDR0000270723, CCF-IRB-5478 |
| Study First Received: | February 5, 2003 |
| Last Updated: | July 23, 2008 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adult glioblastoma recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013