Gefitinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00014170

Purpose

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of glioblastoma multiforme.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have newly diagnosed glioblastoma multiforme.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: gefitinib	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase II Study Of ZD 1839 (NSC 715055) In Newly Diagnosed Patients With Glioblastoma (Grade 4 Astrocytoma)

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: ZD1839

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:	March 2001
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

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.
Determine the toxic effects of this drug in these patients.
Assess fatigue, depression, excessive daytime somnolence, and quality of life in patients treated with this drug.
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.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 10.0 g/dL

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST no greater than 3 times ULN

Renal:

Creatinine no greater than 1.5 times ULN

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy (including polifeprosan 20 with carmustine implant) for this tumor

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
No prior stereotactic radiosurgery or interstitial brachytherapy

Surgery:

No more than 15 weeks since prior surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014170

Show 24 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Joon H. Uhm, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Uhm JH, Ballman KV, Wu W, Giannini C, Krauss JC, Buckner JC, James CD, Scheithauer BW, Behrens RJ, Flynn PJ, Schaefer PL, Dakhill SR, Jaeckle KA. Phase II Evaluation of Gefitinib in Patients with Newly Diagnosed Grade 4 Astrocytoma: Mayo/North Central Cancer Treatment Group Study N0074. Int J Radiat Oncol Biol Phys. 2010 May 24; [Epub ahead of print]

Jaeckle K, Ballman K, Uhm J, et al.: Relationship of administration of enzyme-inducing anticonvulsants (EIAC) to survival in patients with glioblastoma: a North Central Cancer Treatment Group (NCCTG) study. [Abstract] Neuro-Oncology 6 (4): TA-27, 376, 2004.

ClinicalTrials.gov Identifier:	NCT00014170 History of Changes
Other Study ID Numbers:	CDR0000068511, NCCTG-N0074
Study First Received:	April 10, 2001
Last Updated:	June 8, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:

Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012