Description:
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.
Title
- Brief Title: Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme
- Official Title: Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme
Clinical Trial IDs
- ORG STUDY ID:
CDR0000270723
- SECONDARY ID:
CCF-IRB-5478
- NCT ID:
NCT00054496
Conditions
- Brain and Central Nervous System Tumors
Interventions
| Drug | Synonyms | Arms |
|---|
| erlotinib hydrochloride | | |
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.
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
Eligibility 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Response rate |
| Time Frame: | |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Progression-free survival |
| Time Frame: | |
| Safety Issue: | |
| Description: | |
| Measure: | Overall survival |
| Time Frame: | |
| Safety Issue: | |
| Description: | |
| Measure: | Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling |
| Time Frame: | |
| Safety Issue: | |
| Description: | |
| Measure: | Efficacy of tumor EGFR amplification in predicting response to treatment |
| Time Frame: | |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Unknown status |
| Lead Sponsor: | The Cleveland Clinic |
Trial Keywords
- adult glioblastoma
- recurrent adult brain tumor
- adult giant cell glioblastoma
- adult gliosarcoma
Last Updated
January 10, 2014
