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Gefitinib Plus Temozolomide in Treating Patients With Malignant Primary Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00027625
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 27, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining gefitinib with temozolomide in treating patients who have malignant primary glioma.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: gefitinib Drug: temozolomide Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of gefitinib when given in combination with temozolomide in patients with malignant primary glioma.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study of gefitinib. Patients are stratified according to use of concurrent enzyme-inducing anti-epileptic drugs (yes vs no).

Patients receive oral gefitinib once daily on days 1-35 and oral temozolomide once daily on days 8-12 for the first course only. For the second and subsequent courses, patients receive oral gefitinib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 2 months for 1 year and then every 3-6 months thereafter.

PROJECTED ACCRUAL: Approximately 3-42 patients will be accrued for this study within 1-14 months.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Study Of ZD 1839 And Temozolomide For The Treatment Of Gliomas
Actual Study Start Date : January 28, 2002
Actual Primary Completion Date : March 17, 2005
Actual Study Completion Date : November 1, 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignant primary glioma

    • Glioblastoma multiforme
    • Anaplastic astrocytoma
    • Anaplastic oligodendroglioma
    • Anaplastic mixed oligoastrocytoma
    • Malignant astrocytoma not otherwise specified
  • Stable or progressive disease

    • Progressive disease after interstitial brachytherapy or stereotactic radiosurgery must be confirmed by positron emission tomography or thallium scan, magnetic resonance spectroscopy, or surgical biopsy
  • Prior treatment for no more than 3 prior relapses allowed



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • More than 8 weeks


  • WBC greater than 3,000/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 120,000/mm^3
  • Hemoglobin greater than 10 g/dL (transfusion allowed)


  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT less than 1.5 times ULN


  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection
  • No other concurrent significant medical illness that would preclude study participation
  • No significant gastrointestinal risk factors (e.g., active ulcerative colitis) within the past 6 months
  • No other malignancy within the past 3 years except non-melanoma skin cancer or carcinoma in situ of the cervix


Biologic therapy:

  • At least 1 week since prior interferon
  • No concurrent filgrastim (G-CSF) during the first course of study therapy


  • At least 2 weeks since prior vincristine
  • At least 3 weeks since prior procarbazine
  • At least 6 weeks since prior nitrosoureas
  • Prior or concurrent temozolomide allowed if there is no evidence of progression while receiving therapy

Endocrine therapy:

  • At least 1 week since prior tamoxifen
  • Must be on a stable dose of corticosteroids for at least 5 days


  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy


  • See Disease Characteristics
  • At least 1 week since prior surgical resection


  • Recovered from all prior therapy
  • No prior gefitinib
  • At least 1 week since prior non-cytotoxic agents except radiosensitizers
  • At least 4 weeks since prior cytotoxic therapy
  • At least 4 weeks since prior investigational agents
  • At least 3 years since prior therapy for other malignancy
  • Concurrent therapeutic agents allowed at stable dosage
  • Concurrent enzyme-inducing anti-epileptic drugs allowed if continued during study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00027625

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United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143-0128
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75390-9154
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-6220
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
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Study Chair: Michael Prados, MD UCSF Medical Center at Parnassus
Publications of Results:
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT00027625    
Other Study ID Numbers: NABTC-0102
CDR0000069049 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors