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- Klinische proef NCT00400374
Secondary Primary Tumor Prevention With EGFR, OSI-774, and Cyclooxygenase-2
Phase I Study of Secondary Primary Tumor Prevention With Epidermal Growth Factor Receptor (EGFR), Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva™), and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Early Stage (Stage I/II) Squamous Cell Carcinoma of Head and Neck
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This is a phase I study of second primary tumor prevention in early stage (stage I/II) patients diagnosed with squamous cell carcinoma of the head and neck (SCCHN).
The study will evaluate the effect on cells and clinical response to study medications: Epidermal Growth Factor Receptor (EGFR), Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva™), and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib). The side effects of the medications will be assessed, and chemicals in the cells will be evaluated both before and after medication is administered that may show how the drugs work. This information will help researchers determine whether additional studies with these drugs should be conducted to determine if the drugs can help prevent pre-cancerous lesions from becoming cancerous.
SCCHN accounts for 5% of all cancer, and there is an incidence of approximately 37,200 new cases in the United States per year with 11,000 deaths. The five-year survival rate for patients with SCCHN in the United States and other developed countries is still poor, approximately 40%, comparable to the five-year survival rate in the 1970s despite advances in detection, surgery, radiation, and chemotherapy. Thus, a preventative approach before the development of invasive cancer or second primary tumors (SPTs) is highly desirable and novel strategies to reduce cancer incidence in SCCHN and other tobacco-carcinogen related malignancies are being pursued.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Emory University winship Cancer Institute
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients must have, or have previously had, stage I (T1NO) or stage II (T2NO) squamous cell carcinoma of the head and neck.
- Tumor sites include oral cavity (buccal mucosal, gingival, floor of mouth, dorsal/ventral tongue, pharyngeal wall), oropharynx, larynx (glottis, supraglottis, subglottis, epiglottis) hypopharynx, paranasal sinus and nasal cavity.
- May have oral pre-malignant lesions (i.e., hyperplasia, dysplasia, carcinoma in situ) provided their Stage I or II disease has been definitively treated.
- Must have been free of disease for a minimum period of 8 weeks up to maximum of 3 years following completion of surgery and/or radiotherapy.
- Must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-1.
- Patients must be 18 years of age or greater.
- Female patients of childbearing potential must practice adequate contraception and have a negative pregnancy test (β-HCG).
- Must be able to swallow the Erlotinib and Celecoxib pills.
- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Exclusion Criteria:
- Acute intercurrent illness or those who had surgery within the preceding 4 weeks unless they have fully recovered.
- History of previous malignancies other than squamous cell carcinoma of the head and neck unless the cancer was non-melanoma skin cancer.
- Participants who are pregnant or breast feeding.
- Documented history of coagulopathy and/or those taking warfarin or warfarin-derivative anticoagulants within 6 months of entry into the study.
- Hypertension not adequately controlled by medication as shown by a systolic ≥180 @ screening.
- Documented history of interstitial lung disease.
- Known connective tissue disease.
- Participated in a clinical trial of an investigational drug within 12 months prior to enrollment.
- Any active cardiovascular events including angina, unstable angina, palpitation, tachycardia, arrhythmia, or participant has had a recent cerebrovascular accident (stroke) or Myocardial Infarction (< 6 months).
- Any history of clinically significant ventricular arrythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes).
- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Erlotinib, Celecoxib
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Patients will be given Erlotinib (dose escalation from 50 mg, 75 mg, and 100 mg) once daily continuously for 6 months.
Andere namen:
Celecoxib, 400 mg, daily for 6 months.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Define biologic dose of Erlotinib and Celecoxib in Erlotinib plus Celecoxib in patients with early stage (I/II) SCCHN. Improve overall survival rate by reducing SPTs and recurrence with combination of Erlotinib and Celecoxib.
Tijdsspanne: 6 months
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6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Assess tolerability and toxicity associated with combination of Erlotinib and toxicity associated with combination of Erlotinib and Celecoxib for patients with early stage (I/II) SCCHN.
Tijdsspanne: 6 months
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6 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Dong Shin, MD, Emory University winship Cancer Institute
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata
- Neoplasmata per site
- Hoofd- en nekneoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Agenten van het perifere zenuwstelsel
- Enzymremmers
- Pijnstillers
- Sensorische systeemagenten
- Ontstekingsremmers, niet-steroïde
- Pijnstillers, niet-narcotisch
- Ontstekingsremmende middelen
- Antireumatische middelen
- Cyclo-oxygenaseremmers
- Antineoplastische middelen
- Proteïnekinaseremmers
- Cyclo-oxygenase 2-remmers
- Erlotinibhydrochloride
- Celecoxib
Andere studie-ID-nummers
- IRB00021851
- 5R01CA112643 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Erlotinib
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Fox Chase Cancer CenterMillennium Pharmaceuticals, Inc.BeëindigdNiet-kleincellige longkanker uitgezaaid | Terugkerende niet-kleincellige longkankerVerenigde Staten
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National Cancer Institute (NCI)University of Chicago; City of Hope Medical Center; University of Southern California en andere medewerkersVoltooidNiet-kleincellig longcarcinoomVerenigde Staten
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AVEO Pharmaceuticals, Inc.Biodesix, Inc.BeëindigdNiet-kleincellige longkankerKorea, republiek van, Verenigde Staten, Australië, Taiwan, Singapore, Hongkong, Italië
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PfizerVoltooidCarcinoom, niet-kleincellige longVerenigde Staten
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New Mexico Cancer Care AllianceVoltooidGevorderde maligniteiten van solide tumorenVerenigde Staten
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Merck Sharp & Dohme LLCVoltooid
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Grupo de Investigación Clínica en Oncología RadioterapiaVoltooidPlaveiselcelcarcinoom van het hoofd en de halsSpanje
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Sidney Kimmel Cancer Center at Thomas Jefferson...Genentech, Inc.VoltooidCarcinoom, niet-kleincellige longVerenigde Staten
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University of ChicagoNational Cancer Institute (NCI)VoltooidKwaadaardig peritoneaal mesothelioomVerenigde Staten
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PharmaMarVoltooidGeavanceerde kwaadaardige solide tumorenSpanje, Verenigde Staten