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Phase II Study Of ZD1839 (NSC 715055) In Newly Diagnosed Patients With Glioblastoma (Grade 4 Astrocytoma)

Phase 2
18 Years
Not Enrolling
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

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Trial Information

Phase II Study Of ZD1839 (NSC 715055) In Newly Diagnosed Patients With Glioblastoma (Grade 4 Astrocytoma)


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

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.

Inclusion Criteria:

- Histologically confirmed newly diagnosed WHO grade IV astrocytoma (glioblastoma
multiforme) or gliosarcoma

- No WHO grade III anaplastic astrocytoma, oligodendroglioma, or mixed

- 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

- See Disease Characteristics

- No prior stereotactic radiosurgery or interstitial brachytherapy

- No more than 15 weeks since prior surgery

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

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.

Outcome Time Frame:

52 weeks

Safety Issue:


Principal Investigator

Joon Uhm

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Food and Drug Administration

Study ID:




Start Date:

March 2001

Completion Date:

Related Keywords:

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Glioblastoma
  • Gliosarcoma



North Central Cancer Treatment Group Rochester, Minnesota  55905