- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00072072
Celecoxib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase I Trial Of A COX-2 Inhibitor (Celecoxib) In Combination With An EGFR Inhibitor (OSI-774) In Metastatic Non-Small Cell Lung Cancer
RATIONALE: Celecoxib may stop the growth of cancer by stopping blood flow to the tumor. Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining celecoxib with erlotinib may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with erlotinib in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
Primary
- Determine the biologically active dose of celecoxib administered with erlotinib in patients with stage IIIB or IV non-small cell lung cancer.
- Determine the toxicity profile of this regimen in these patients.
Secondary
- Determine the clinical activity of this regimen, in terms of reduction in tumor burden, in these patients.
- Correlate biological endpoints with cyclooxygenase-2 and epidermal growth factor receptor inhibition in patients treated with this regimen.
OUTLINE: This is a nonrandomized, dose-escalation study of celecoxib.
Patients receive oral erlotinib once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue treatment beyond 2 courses at the investigator's discretion.
Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) and biologically active dose (BAD) are determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). The BAD is defined as the maximum decrease in the level of PGE_2 where no DLT occurs.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 21-27 patients will be accrued for this study.
Studietype
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
California
-
Los Angeles, California, Forente stater, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIB or IV
- Measurable disease
- Progressive disease after at least 2 prior standard chemotherapy regimens OR refused standard chemotherapy
- No active CNS metastases
PATIENT CHARACTERISTICS:
Age
- 21 and over
Performance status
- ECOG 0-2
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 1.5 mg/dL
- Transaminases no greater than 2.5 times upper limit of normal (ULN)
- PT and/or PTT no greater than 1.5 times ULN
Renal
- Creatinine no greater than 2 mg/dL
Cardiovascular
- No New York Heart Association class III or IV cardiac disease
- No myocardial infarction within the past year
- No symptomatic ventricular arrhythmia
- No symptomatic conduction abnormality
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior gastrointestinal ulceration, bleeding, or perforation
- No hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or other reagents used in this study
- No concurrent disease or medical condition that would preclude study treatment or compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy
Endocrine therapy
- More than 4 weeks since prior corticosteroids
No concurrent steroids (including chronic use)
- Concurrent topical steroids allowed
Radiotherapy
- More than 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- More than 4 weeks since prior non-cytotoxic investigational agents
- More than 3 days since prior nonsteroidal anti-inflammatory drugs (NSAIDs)
- No prior cyclooxygenase-2 (COX-2) inhibitors for metastatic NSCLC
- No prior epidermal growth factor receptor inhibitor for metastatic NSCLC
- No concurrent COX-2 inhibitors
- No concurrent NSAIDs
- No concurrent fluconazole or lithium
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Karen Rickard, City of Hope Comprehensive Cancer Center
- Hovedetterforsker: Robert A. Figlin, MD, FACP, Jonsson Comprehensive Cancer Center
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karsinom, ikke-småcellet lunge
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystemet
- Enzymhemmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Syklooksygenase-hemmere
- Antineoplastiske midler
- Proteinkinasehemmere
- Syklooksygenase 2-hemmere
- Erlotinib hydroklorid
- Celecoxib
Andre studie-ID-numre
- CDR0000335434
- UCLA-0306083
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Lungekreft
-
Yonsei UniversityFullført
-
Novartis PharmaceuticalsFullførtNevroendokrine svulster | Avansert NET av GI Origin | Advanced NET of Lung OriginForente stater, Colombia, Italia, Taiwan, Storbritannia, Belgia, Tsjekkia, Tyskland, Japan, Saudi-Arabia, Canada, Nederland, Spania, Korea, Republikken, Libanon, Østerrike, Kina, Hellas, Sør-Afrika, Thailand, Ungarn, Tyrkia, Polen, Slov... og mer
-
The Cleveland ClinicTilbaketrukketOne Lung Ventillation (OLV) | To lungeventilasjon (TLV) | Positivt End Expiratory Pressure (PEEP) | Null sluttekspirasjonstrykk (ZEEP)
-
Assiut UniversityHar ikke rekruttert ennåLungekreft | Lungeskade | Bleb Lung
-
RenJi HospitalRekrutteringMultiple Synchronous Lung Cancers (MSLC)Kina
-
Poitiers University HospitalFullførtEndobronchial Transbronchial Needle Aspiration Lung Cancer Procore
-
University of LorraineFullførtBare barn | Spontan pneumothorax | Idiopatisk pneumotoraks | Bleb LungFrankrike
-
AHS Cancer Control AlbertaCross Cancer InstituteFullførtOmfattende Stage Small Cel Lung CancerCanada
-
Damascus UniversityUniversity Children's HospitalFullførtEsophageal atresi | One Lung Ventilation OLV | Hydrocystoma | Pneumonektomi | Pleura; AbscessDen syriske arabiske republikk
-
Ministry of Health, Saudi ArabiaHar ikke rekruttert ennåLuftveissykdom | Prematuritet | Ventilator Lung; Nyfødt
Kliniske studier på celecoxib
-
Chong Kun Dang PharmaceuticalFullførtArtrose HåndKorea, Republikken
-
Hoffmann-La RocheFullførtLeddgiktDen russiske føderasjonen
-
Yooyoung Pharmaceutical Co., Ltd.CliPS Co., LtdFullført
-
Samsung Medical CenterThe Korean Urological AssociationTilbaketrukketBenign prostatahyperplasiKorea, Republikken
-
Yooyoung Pharmaceutical Co., Ltd.CliPSBnCRekruttering
-
Seoul National University HospitalFullført
-
Dr. Reddy's Laboratories LimitedFullført
-
Targeted Therapy Technologies, LLCRekrutteringMacula ødem | Epiretinal membran | Branch retinal vene okklusjon | Strålingsretinopati | Sentral serøs retinopati med gropen på optisk plate | Commotio Retinae | VitrittForente stater
-
Seoul National University HospitalFullførtIntracerebral blødningKorea, Republikken
-
Peking University Third HospitalHar ikke rekruttert ennå