Clinical trial · Interventional
Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme
Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme
NCT00054496CI-TRIAL-00013411unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
Secondary outcomes (4)
- measure
- Progression-free survival
- measure
- Overall survival
- measure
- Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling
- measure
- Efficacy of tumor EGFR amplification in predicting response to treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
* ZonisamideReferences
Publications (0)
Data not yet available
No reference posted for this study.