Gefitinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Phase II Study Of ZD1839 (NSC 715055) In Newly Diagnosed Patients With Glioblastoma (Grade 4 Astrocytoma)
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
Minnesota
-
Rochester, Minnesota, Vereinigte Staaten, 55905
- North Central Cancer Treatment Group
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Treatment (gefitinib)
Patients receive oral gefitinib daily.
Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Korrelative Studien
Mündlich gegeben
Andere Namen:
Nebenstudien
Nebenstudien
Andere Namen:
Korrelative Studien
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Survival
Zeitfenster: 52 weeks
|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Post-RT progression-time
Zeitfenster: From start of study therapy to date of disease progression or last follow-up, assessed up to 10 years
|
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
|
|
Toxicity patterns assessed using NCI CTC version 2.0
Zeitfenster: Up to 10 years
|
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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Joon Uhm, North Central Cancer Treatment Group
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach histologischem Typ
- Neubildungen
- Neubildungen, Drüsen und Epithelien
- Astrozytom
- Gliom
- Neubildungen, Neuroepithel
- Neuroektodermale Tumoren
- Neoplasmen, Keimzelle und Embryonal
- Neubildungen, Nervengewebe
- Glioblastom
- Gliosarkom
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Proteinkinase-Inhibitoren
- Gefitinib
Andere Studien-ID-Nummern
- NCI-2012-01855
- U10CA025224 (US NIH Stipendium/Vertrag)
- N0074
- CDR0000068511
- NCCTG-N0074
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Labor-Biomarker-Analyse
-
Vanderbilt University Medical Center4DMedicalAbgeschlossen
-
Central and North West London NHS Foundation TrustBritish HIV Association (BHIVA)Noch keine RekrutierungHIV-Infektionen | Hepatitis B
-
Duke UniversityZurückgezogenAntikoagulations- und Thrombose-Point-of-Care-Test (AT-POCT)Vereinigte Staaten
-
Columbia UniversityAbgeschlossen
-
McGill University Health Centre/Research Institute...Northwestern UniversityRekrutierungApnoe der FrühgeburtlichkeitKanada
-
Emory UniversityDermatology FoundationBeendetKutaner Lupus erythematodesVereinigte Staaten