NCT00014170

Brief Summary

Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of glioblastoma multiforme. Phase II trial to study the effectiveness of gefitinib in treating patients who have newly diagnosed glioblastoma multiforme.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2001

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

June 10, 2003

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Last Updated

July 16, 2013

Status Verified

June 1, 2013

Enrollment Period

2.3 years

First QC Date

April 10, 2001

Last Update Submit

July 15, 2013

Conditions

Adult Giant Cell GlioblastomaAdult GlioblastomaAdult Gliosarcoma

Outcome Measures

Primary Outcomes (1)

  • Survival

    The proportion of 'successes' will be estimated using the binomial point estimator (number of 'successes' divided by the total number of evaluable patients) and standard binomial 90% confidence interval estimates. In the unlikely event that accrual has not been completed before the interim analyses are performed, the Duffy-Santner lgorithm will be used to calculate 90% confidence intervals.

    52 weeks

Secondary Outcomes (2)

  • Post-RT progression-time

    From start of study therapy to date of disease progression or last follow-up, assessed up to 10 years

  • Toxicity patterns assessed using NCI CTC version 2.0

    Up to 10 years

Study Arms (1)

Treatment (gefitinib)

EXPERIMENTAL

Patients receive oral gefitinib daily. Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Drug: gefitinibOther: pharmacological studyOther: laboratory biomarker analysisOther: questionnaire administrationProcedure: quality-of-life assessment

Interventions

gefitinibDRUG

Given orally

Also known as: Iressa, ZD 1839
Treatment (gefitinib)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (gefitinib)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (gefitinib)
questionnaire administrationOTHER

Ancillary studies

Treatment (gefitinib)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Treatment (gefitinib)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed newly diagnosed WHO grade IV astrocytoma (glioblastoma multiforme) or gliosarcoma
  • No WHO grade III anaplastic astrocytoma, oligodendroglioma, or mixed oligoastrocytoma
  • Completed standard external beam radiotherapy within the past 2-5 weeks
  • No evidence of tumor progression during radiotherapy
  • Performance status - ECOG 0-2
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 10.0 g/dL
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 3 times ULN
  • Creatinine no greater than 1.5 times ULN
  • No other active malignancy
  • No uncontrolled infection
  • No other severe concurrent disease that would preclude study participation
  • Not pregnant or nursing
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

GlioblastomaGliosarcoma

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Joon Uhm

    North Central Cancer Treatment Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2001

First Posted

June 10, 2003

Study Start

March 1, 2001

Primary Completion

July 1, 2003

Last Updated

July 16, 2013

Record last verified: 2013-06

Locations

US(1)