Clinical trial NCT00054496: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: adult glioblastoma
recurrent adult brain tumor
adult giant cell glioblastoma
adult gliosarcoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-02-06
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Response rate
Secondary outcomes:
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
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Michael A. Vogelbaum, MD, PhD
role: STUDY_CHAIR
References: