Gefitinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Adult Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00014170
• Other study ID #: NCI-2012-01855
• Secondary ID: N0074CDR00000685
• Status: Completed
• Phase: Phase 2
• First received: April 10, 2001
• Last updated: July 15, 2013
• Start date: March 2001

Study information

• Verified date: June 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• gefitinib
Given orally

Other:
• pharmacological study
Correlative studies
• laboratory biomarker analysis
Correlative studies
• questionnaire administration
Ancillary studies

Procedure:
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	North Central Cancer Treatment Group	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	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.	52 weeks	No
Secondary	Post-RT progression-time	Kaplan-Meier survival curves and logrank tests will be used.	From start of study therapy to date of disease progression or last follow-up, assessed up to 10 years	No
Secondary	Toxicity patterns assessed using NCI CTC version 2.0	Will be analyzed descriptively. Toxicity score calculated as the sum of the maximum toxicity grades recorded for each of the types of adverse reactions observed during the trial.	Up to 10 years	Yes