NCT00227032

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib in treating patients with progressive glioblastoma multiforme.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

March 6, 2012

Status Verified

March 1, 2012

Enrollment Period

2.4 years

First QC Date

September 23, 2005

Last Update Submit

March 5, 2012

Conditions

Brain and Central Nervous System Tumors

Keywords

adult giant cell glioblastomaadult gliosarcomaadult glioblastomarecurrent adult brain tumor

Outcome Measures

Primary Outcomes (2)

  • Progression-free survival

    Progression -free survival will be measured by radographic response using RECIST critera.

    12 months

  • Correlation between presence of the EGFRvIII mutation with treatment outcomes

    6 months

Study Arms (2)

Subjects receiving EIAEDs

EXPERIMENTAL

Patients will be stratified according to concurrent use of enzyme inducing anti-epileptic drugs (EIAED)

Drug: erlotinib hydrochloride

Subjects NOT taking EIAEDs

EXPERIMENTAL

Patients will be stratified according to concurrent use of enzyme inducing anti-epileptic drugs (EIAED)

Drug: erlotinib hydrochloride

Interventions

erlotinib hydrochlorideDRUG

300 mg, per day for subjects taking EIAEDs 150 mg, per day for those NOT taking EIAEDs

Subjects NOT taking EIAEDsSubjects receiving EIAEDs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme (or high-grade glioma that is behaving clinically and/or radiographically like glioblastoma multiforme) * Progressed after first-line therapy (e.g., surgery, chemotherapy, or radiotherapy) PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * ANC \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Hemoglobin \> 8.5 g/dL * ALT and AST \< 2 times upper limit of normal (ULN) * Alkaline phosphatase \< 2 times ULN * Bilirubin \< 1.5 mg/dL * Creatinine \< 1.5 mg/dL OR creatinine clearance \> 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No diagnosis or history of significant renal or hepatic disease * No contraindication (e.g., mass effect, brain shift) to lumbar puncture procedure * No active infection * No diagnosis or history of corneal abnormalities * No diagnosis or history of malabsorptive syndrome or other disorder affecting gastrointestinal absorption * No history of hypersensitivity reactions to midazolam hydrochloride (CYP3A4 biomarker) PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaGliosarcomaBrain Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Celeste Lindley, PharmD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

  • Frances A. Collichio, MD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2005

First Posted

September 27, 2005

Study Start

September 1, 2005

Primary Completion

February 1, 2008

Study Completion

March 1, 2008

Last Updated

March 6, 2012

Record last verified: 2012-03

Locations

US(1)