- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00054496
Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme
Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme
RATIONALE: Erlotinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or progressive glioblastoma multiforme.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Determine the response rate of patients with recurrent or progressive glioblastoma multiforme treated with erlotinib.
- Determine the progression-free and overall survival of patients treated with this drug.
OUTLINE: Patients receive oral erlotinib daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- Rekruttering
- Cleveland Clinic Taussig Cancer Center
-
Kontakt:
- Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente
- Telefonnummer: 866-223-8100
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme
Radiographic evidence of recurrence or progression
- Biopsies to confirm tumor recurrence allowed if a sufficent percentage of cases are confirmed to be recurrent tumor
- Previously treated with optimal radiotherapy and at least 1 cytotoxic chemotherapy regimen
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2 times normal
- Alkaline phosphatase no greater than 2 times normal
- ALT no greater than 3 times normal
Renal
- BUN no greater than 1.5 times normal OR
- Creatinine no greater than 1.5 times normal
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No medical condition that would interfere with oral administration of erlotinib
- No other medical or psychiatric illness that would preclude study therapy
- No active infection
- No other malignancy within the past 3 years except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy for brain cancer
- No concurrent biologic therapy for brain cancer
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent chemotherapy for brain cancer
Endocrine therapy
- Concurrent glucocorticosteroids allowed
- No concurrent hormonal therapy for brain cancer
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Other
- No prior epidermal growth factor receptor (EGFR) inhibitor
- No concurrent EGFR inhibitor
- No other concurrent antineoplastic therapy
No concurrent anti-epileptic agents other than modest- or non-enzyme-inducing drugs such as the following:
- Gabapentin
- Lamotrigine
- Divalproex
- Felbamate
- Levetiracetam
- Tiagabine
- Topiramate
- Zonisamide
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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|
Svarprocent
|
Sekundære resultatmål
Resultatmål |
|---|
|
Progressionsfri overlevelse
|
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Samlet overlevelse
|
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Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling
|
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Efficacy of tumor EGFR amplification in predicting response to treatment
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Michael A. Vogelbaum, MD, PhD, The Cleveland Clinic
Datoer for undersøgelser
Studer store datoer
Studiestart
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i nervesystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Astrocytom
- Gliom
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Glioblastom
- Neoplasmer i nervesystemet
- Neoplasmer i centralnervesystemet
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Proteinkinasehæmmere
- Erlotinib hydrochlorid
Andre undersøgelses-id-numre
- CDR0000270723
- CCF-IRB-5478
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