- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
California
-
Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Karen Rickard, City of Hope Comprehensive Cancer Center
- Ledende efterforsker: Robert A. Figlin, MD, FACP, Jonsson Comprehensive Cancer Center
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
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
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Cyclooxygenase-hæmmere
- Antineoplastiske midler
- Proteinkinasehæmmere
- Cyclooxygenase 2-hæmmere
- Erlotinib hydrochlorid
- Celecoxib
Andre undersøgelses-id-numre
- CDR0000335434
- UCLA-0306083
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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