Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

NeuroTherapia, Inc.

Status and phase: Unknown; Phase 2

Conditions: Brain and Central Nervous System Tumors

Treatments: Drug: erlotinib hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00054496

CCF-IRB-5478

CDR0000270723

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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