Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00054496
• Other study ID #: CDR0000270723
• Secondary ID: CCF-IRB-5478
• Status: Recruiting
• Phase: Phase 2
• First received: February 5, 2003
• Last updated: January 9, 2014
• Start date: August 2002

Study information

• Verified date: December 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Nervous System Neoplasms

Intervention

Drug:
• erlotinib hydrochloride

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Secondary	Progression-free survival			No
Secondary	Overall survival			No
Secondary	Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling			No
Secondary	Efficacy of tumor EGFR amplification in predicting response to treatment			No