Know Cancer

forgot password

A Phase I Study Of ZD 1839 And Temozolomide For The Treatment Of Gliomas

Phase 1
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

Thank you

Trial Information

A Phase I Study Of ZD 1839 And Temozolomide For The Treatment Of Gliomas


- 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

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael Prados, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UCSF Medical Center at Parnassus


United States: Federal Government

Study ID:




Start Date:

January 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
UCSF Comprehensive Cancer Center San Francisco, California  94115
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182