Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

NCT ID: NCT00054496

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

erlotinib hydrochloride

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Principal Investigators

Michael A. Vogelbaum, MD, PhD

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente

Role: primary

866-223-8100

Other Identifiers

CCF-IRB-5478

Identifier Type: -

Identifier Source: secondary_id

CDR0000270723

Identifier Type: -

Identifier Source: org_study_id