- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00062179
Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
A Randomized Double Blind Phase II Study of Preoperative Celecoxib/Paclitaxel/Carboplatin for Stage IIIA Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy such as paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug, may stop the growth of tumor cells by stopping blood flow to the tumor, and/or may block the enzymes necessary for tumor cell growth. Giving combination chemotherapy with celecoxib before surgery may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving paclitaxel together with carboplatin followed by surgery works compared to giving paclitaxel together with carboplatin and celecoxib followed by surgery in treating patients with stage IIIA non-small cell lung cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Compare the complete pathological response rate and/or minimal residual microscopic disease in patients with stage IIIA non-small cell lung cancer treated with preoperative paclitaxel and carboplatin with vs without celecoxib.
- Compare the clinical response rate in patients treated with these regimens.
- Compare chemotherapy-related toxicity in patients treated with these regimens.
- Compare the time to progression, disease-free survival, and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to use of aspirin for prior cardiovascular disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days 1, 22, and 43. Patients also receive oral celecoxib twice daily beginning on day 1 and continuing until the morning of surgical resection.
- Arm II: Patients receive paclitaxel and carboplatin as in arm I and an oral placebo twice daily beginning on day 1 and continuing until the morning of surgical resection.
In both arms, patients undergo surgical resection and complete mediastinal lymph node dissection within 3-6 weeks after completion of chemotherapy. Patients resume oral celecoxib or placebo twice daily within 28-42 days after surgery and continue until 3 years from the date of randomization in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3-6 months.
PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
California
-
Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
-
-
New York
-
New York, New York, Forenede Stater, 10021
- New York Weill Cornell Cancer Center at Cornell University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with biopsy proven non-small cell lung cancer clinical stage IIIA
- Mediastinoscopy positive N2 disease is mandatory
- The disease must be deemed potentially resectable by the thoracic surgeon
- Karnofsky performance status > 80%
- Pulmonary function must be acceptable for surgery according to institutional standards
Acceptable hepatic, renal and bone marrow function
- Total serum bilirubin < ULN
- AST and/or ALT < 2.5x ULN
- Alkaline phosphatase < 2.5x ULN
- Serum creatinine < 2.0 mg/mm3
- White blood cell > 3000/mm3
- Platelets > 100,000/mm3
- Age 18 or older
- Willingness to abstain from chronic use of NSAIDs (defined as > 7 days of continuous therapy per month OR defined as frequency of > 3 times per week) for the duration of the study. For those patients on NSAIDs prior to study entry, cessation of the drug for 72 hours prior to study entry is required
- Patients on low-dose ASA (<325 mg daily) for prophylaxis of cardiovascular disease prior to study entry may remain on that dose of ASA during this trial
- No anticipated chronic use of steroids. Patients may take the inhaled steroids mometasone or fluticasone if medically indicated
Exclusion Criteria:
- Patients with known hypersensitivity or allergic reactions to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates
- Hypersensitivity to paclitaxel
- Significant medical or psychiatric illness that would interfere with patient compliance
- Prior malignancy within the last 3 years with the exception of non-melanoma skin cancer
- Receiving other investigational agents during the course of this study or are < 3 weeks from completion of other clinical trial therapy
- Patients with a history of peptic ulcer disease, bleed disorder, irritable bowel disease, inflammatory bowel syndrome, chronic diarrhea or bowel obstruction within 5 years
- Patients receiving enzyme-inducing anticonvulsants are ineligible. Patients who require concomitant therapy with NSAIDs or COX-2 inhibitors
- Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment
- Patients receiving lithium or fluconazole
- Pregnant women or women of childbearing potential that refuse to use effective contraception during the period of chemotherapy.
- Patients with a significant history of unstable cardiovascular disease
- Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: paclitaxel/carboplatin/celecoxib
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion Carboplatin: dosed at an AUC of 6 by the Calvert Formula Celecoxib: 400 mg po BID 3 cycles of paclitaxel and carboplatin 21 days apart celecoxib 3-7 days before first dose of chemotherapy
|
Carboplatin: dosed at an AUC of 6 by the Calvert Formula 3 cycles of carboplatin 21 days apart
Celecoxib: 400 mg po BID celecoxib 3-7 days before first dose of chemotherapy
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion 3 cycles of paclitaxel 21 days apart
|
Placebo komparator: paclitaxel/Carboplatin/Placebo
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion Carboplatin: dosed at an AUC of 6 by the Calvert Formula Placebo 3 cycles of paclitaxel and carboplatin 21 days apart Placebo 3-7 days before first dose of chemotherapy
|
Carboplatin: dosed at an AUC of 6 by the Calvert Formula 3 cycles of carboplatin 21 days apart
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion 3 cycles of paclitaxel 21 days apart
placebo 3-7 days before first dose of chemotherapy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Rates of complete pathological response and/or minimal residual microscopic disease at 3 years
Tidsramme: 3 years
|
3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Clinical response at 3 years
Tidsramme: 3 years
|
3 years
|
Difference in time to progression, disease-free survival, and overall survival between Arm I and Arm II at 3 years
Tidsramme: 3 years
|
3 years
|
Toxicity in patients with paclitaxel/carboplatin/celecoxib vs. paclitaxel/carboplatin/placebo
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Karen Rickard, City of Hope Comprehensive Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
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
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Cyclooxygenase 2-hæmmere
- Carboplatin
- Paclitaxel
- Celecoxib
Andre undersøgelses-id-numre
- CDR0000304540
- UCLA-0208074
- NYH-CMC-0902-464
- PHARMACIA-COXAON-0509-106
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