Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

• ClinicalTrials.gov Identifier: NCT00054496
• Recruitment Status: Unknown
• First Posted: February 6, 2003
• Last Update Posted: January 10, 2014
• Sponsor: The Cleveland Clinic
• Information provided by: National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: February 5, 2003
• First Posted Date: February 6, 2003
• Last Update Posted Date: January 10, 2014
• Study Start Date: August 2002
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: November 8, 2006): Response rate
• Original Primary Outcome Measures: Not Provided
• Change History: Complete list of historical versions of study NCT00054496 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: November 8, 2006)

• Progression-free survival
• Overall survival
• Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling
• Efficacy of tumor EGFR amplification in predicting response to treatment

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Brain and Central Nervous System Tumors
• Intervention: Drug: erlotinib hydrochloride
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 8, 2006): 73
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00054496
• Other Study ID Numbers: CDR0000270723; CCF-IRB-5478
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: The Cleveland Clinic
• Collaborators: Not Provided

Investigators

• Study Chair: Michael A. Vogelbaum, MD, PhD; The Cleveland Clinic

• PRS Account: National Cancer Institute (NCI)
• Verification Date: December 2006