cropped color_logo_with_background.png

Clinical Trial Finder

Gefitinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception.
  • - No prior chemotherapy (including polifeprosan 20 with carmustine implant) for this tumor.
  • - See Disease Characteristics.
  • - No prior stereotactic radiosurgery or interstitial brachytherapy.
- No more than 15 weeks since prior surgery

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00014170
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Joon Uhm
Principal Investigator Affiliation North Central Cancer Treatment Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
Additional Details

OBJECTIVES:

  • I. Determine treatment effectiveness of gefitinib, in terms of response rate, time to progression, survival at 52 weeks, progression-free survival at 6 months, and overall survival, in patients with newly diagnosed glioblastoma multiforme.
  • II. Determine the toxic effects of this drug in these patients.
  • III. Assess fatigue, depression, excessive daytime somnolence, and quality of life in patients treated with this drug.
  • IV. Assess individual variation in responses, pharmacokinetic parameters, and/or biological correlates due to genetic differences in enzymes involved in transport, metabolism, and/or mechanism of action of this drug in these patients.
  • V. Determine if the type of epidermal growth factor receptor affects tumor response and outcome in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients receive oral gefitinib daily. Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before each treatment course, every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients are followed every 8 weeks until tumor progression and then every 3 months for 5 years and annually for up to 10 years. Patients removed from study treatment for reasons other than disease progression are followed every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study within 14 months.

Arms & Interventions

Arms

Experimental: Treatment (gefitinib)

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

Interventions

Drug: - gefitinib

Given orally

Other: - pharmacological study

Correlative studies

Other: - laboratory biomarker analysis

Correlative studies

Other: - questionnaire administration

Ancillary studies

Procedure: - quality-of-life assessment

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

North Central Cancer Treatment Group, Rochester, Minnesota

Status

Address

North Central Cancer Treatment Group

Rochester, Minnesota, 55905

Powered By