Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Safety Issue:
No
Principal Investigator
Michael A. Vogelbaum, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
The Cleveland Clinic
Authority:
Unspecified
Study ID:
CDR0000270723
NCT ID:
NCT00054496
Start Date:
August 2002
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- adult glioblastoma
- recurrent adult brain tumor
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
