- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00058006
Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer
Pilot Randomized Trial Of Adjuvant Celecoxib In Patients With Early Stage Head And Neck And Non-Small Cell Lung Cancers
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent the recurrence of stage I or stage II head and neck cancer or stage I non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to that of a placebo in preventing disease recurrence in patients with stage I or stage II head and neck cancer or stage I non-small cell lung cancer.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
- Compare the rate of new malignancies (recurrences and second primary tumors) in patients with early-stage head and neck cancer or non-small cell lung cancer treated with celecoxib vs placebo.
- Compare the event-free and overall survival of patients treated with this drug vs placebo.
- Determine the toxic effects associated with long-term use of celecoxib in these patients.
- Correlate cyclooxygenase-2 and transforming growth factor (TGF)-beta expression and CYP2C9 and TGF-beta genotypes with the rate of new malignancies and survival of patients treated with this drug vs placebo.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to smoking history (active smokers [including those who quit within 1 year of diagnosis] vs former smokers vs non-smokers), tumor type (lung cancer vs head and neck cancer), and stage (I vs II for head and neck cancer or T1 vs T2 for lung cancer). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral celecoxib twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 24 months in the absence of disease recurrence or unacceptable toxicity.
Patients are followed every 6 months for 5 years or until disease recurrence.
PROJECTED ACCRUAL: A total of 121 patients (approximately 60 per treatment arm) will be accrued for this study.
Studietyp
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60637-1470
- University of Chicago Cancer Research Center
-
Chicago, Illinois, Förenta staterna, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
-
Chicago, Illinois, Förenta staterna, 60612
- Rush Cancer Institute at Rush University Medical Center
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
One of the following histologically confirmed diagnoses:
Stage I non-small cell lung cancer (NSCLC)
- No small cell component
Stage I-II squamous cell cancer of the head and neck
- No WHO type II or III nasopharyngeal cancer
- No sinonasal undifferentiated carcinoma
- No evidence of disease
- Must have undergone surgery or radiotherapy with curative intent within the past 4-24 weeks
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Platelet count at least 50,000/mm^3
Hepatic
- Bilirubin normal
- AST/ALT no greater than 2 times upper limit of normal
Renal
- Creatinine no greater than 2.0 mg/dL
Cardiovascular
- No uncontrolled hypertension
- No severe congestive heart failure
Pulmonary
- No history of asthma caused by cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, or sulfonamides
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- No other prior malignancy (including skin cancer and in situ malignancies)
- No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days
- No prior hypersensitivity reaction to COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides
- No other concurrent medical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- No cumulative oral or IV corticosteroid use totalling more than 2 weeks within the past 3 months
- No concurrent oral steroids for more than 2 consecutive weeks
- Concurrent inhaled steroids allowed
Radiotherapy
- See Disease Characteristics
- No prior definitive radiotherapy for stage I NSCLC
Surgery
- See Disease Characteristics
- Prior pneumonectomy or lobectomy with mediastinal lymph node sampling or dissection for stage I NSCLC allowed
- No prior segmentectomies or wedge resections for stage I NSCLC
Other
- More than 60 days since prior treatment for peptic ulcer disease or gastritis/esophagitis
- No prior NSAID use within the past 30 days at a frequency of 3 or more times a week for more than 2 weeks
- No concurrent NSAIDs (including low-dose aspirin)
- No other concurrent COX-2 inhibitors
- No concurrent fluconazole
- No concurrent lithium
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Maskning: Dubbel
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Athanassios Argiris, MD, Robert H. Lurie Cancer Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- stadium I icke-småcellig lungcancer
- stadium I skivepitelcancer i läppen och munhålan
- stadium II skivepitelcancer i läppen och munhålan
- stadium I skivepitelcancer i paranasala sinus och näshåla
- stadium II skivepitelcancer i paranasala sinus och näshåla
- stadium I skivepitelcancer i hypofarynx
- stadium I skivepitelcancer i struphuvudet
- stadium I skivepitelcancer i nasofarynx
- stadium I skivepitelcancer i orofarynx
- stadium II skivepitelcancer i hypofarynx
- stadium II skivepitelcancer i struphuvudet
- stadium II skivepitelcancer i nasofarynx
- stadium II skivepitelcancer i orofarynx
- stadium II spottkörtelcancer
- spottkörtel skivepitelcancer
- stadium I spottkörtelcancer
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Neoplasmer i huvud och hals
- Lungneoplasmer
- Karcinom, icke-småcellig lunga
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Agenter från det perifera nervsystemet
- Enzyminhibitorer
- Analgetika
- Sensoriska systemagenter
- Antiinflammatoriska medel, icke-steroida
- Analgetika, icke-narkotiska
- Antiinflammatoriska medel
- Antireumatiska medel
- Cyklooxygenashämmare
- Cyklooxygenas 2-hämmare
- Celecoxib
Andra studie-ID-nummer
- NU 02V2
- NU-02V2
- PHARMACIA-NU-02V2
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