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- Klinische proef NCT00073866
Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer
Phase I/II Trial Of Weekly Irinotecan And Docetaxel With The Addition Of Celecoxib In Advanced Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Combining celecoxib with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan and docetaxel when given together with celecoxib and to see how well they work in treating patients with advanced non-small cell lung cancer.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES:
- Determine the recommended phase II dose of docetaxel and irinotecan in combination with celecoxib in patients with advanced non-small cell lung cancer.
- Determine the toxic effects of this regimen in these patients.
- Determine the response rate of patients treated with this regimen.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
- Correlate angiogenesis markers (intratumoral microvessel density and vascular endothelial growth factor [VEGF] expression and serum VEGF) and cyclooxygenase-2 expression with response and survival in patients treated with this regimen.
- Correlate UGT1A1 genotype and CYP3A4 activity with the toxic effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study of docetaxel and irinotecan.
- Phase I: Patients receive docetaxel IV over 60 minutes and irinotecan IV over 30 minutes on days 1 and 8. Patients also receive oral celecoxib twice daily beginning on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of docetaxel and irinotecan until the recommended phase II dose is determined. The recommended phase II dose is defined as the highest dose at which 0 of 3 or 1 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive treatment as in phase I at the recommended phase II dose.
Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 3-70 patients (3-36 for phase I and 16-34 for phase II) will be accrued for this study.
Studietype
Fase
- Fase 2
- Fase 1
Contacten en locaties
Studie Locaties
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Illinois
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Chicago, Illinois, Verenigde Staten, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Evanston, Illinois, Verenigde Staten, 60201
- Evanston Northwestern Health Care - Evanston Hospital
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Joliet, Illinois, Verenigde Staten, 60432
- Silver Cross Hospital
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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
DISEASE CHARACTERISTICS:
Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:
- Stage IV
- Stage IIIB with a malignant pleural effusion
- Locally recurrent and/or persistent disease after locoregional therapy with or without systemic chemotherapy
Unidimensionally measurable disease
- If the only site of measurable disease is in a previously irradiated area must have documented progression of disease in that area
- No CNS metastases
PATIENT CHARACTERISTICS:
Age
- 18 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 normal
- AST and ALT less than 2.5 times upper limit of normal (ULN) (if alkaline phosphatase is normal)
- Alkaline phosphatase less than 4 times ULN (if AST and ALT are normal)
Renal
- Creatinine less than 2.0 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study treatment
- No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
- No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days
- No prior hypersensitivity to cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, sulfonamides, or drugs formulated with polysorbate 80
- No pre-existing grade 2 or greater peripheral neuropathy
- No concurrent medical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 1 week since prior biologic therapy
Phase I patients:
- Any number of prior biologic therapies allowed (e.g., chimeric antibodies or kinase inhibitors)
Phase II patients:
- No prior biologic therapy for recurrent/metastatic disease
- No concurrent filgrastim (G-CSF)
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- No prior irinotecan or docetaxel
Phase I patients:
- Up to 2 prior chemotherapy regimens for recurrent/metastatic disease allowed (chemonaïve patients are also eligible)
Phase II patients:
- At least 1 year since prior adjuvant or neoadjuvant chemotherapy for stage I-IIIA disease
- No prior chemotherapy for recurrent/metastatic disease
Endocrine therapy
- Less than 2 weeks of cumulative oral/IV corticosteroid use within the past 3 months
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
- At least 3 weeks since prior extensive-field radiotherapy for recurrent/metastatic disease
Surgery
- Recovered from prior surgery
Other
- More than 60 days since prior treatment for peptic ulcer disease or gastritis/esophagitis
- No prior NSAIDs at a frequency of more than 3 times per week for a cumulative period of more than 2 weeks within the past 30 days
- No concurrent antiepileptics, cyclosporine, aspirin, or fluconazole
- No concurrent NSAIDs
- No other concurrent COX-2 inhibitors
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Athanassios Argiris, MD, Robert H. Lurie Cancer Center
Publicaties en nuttige links
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 (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Longneoplasmata
- Carcinoom, niet-kleincellige long
- 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
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Topoisomeraseremmers
- Cyclo-oxygenase 2-remmers
- Topoisomerase I-remmers
- Docetaxel
- Celecoxib
- Irinotecan
Andere studie-ID-nummers
- NU 01L2
- NU-01L2
- PHARMACIA-NU-01L2
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 .
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidAdenocarcinoom van de dunne darm | Stadium III Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIA Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIB dunne darm adenocarcinoom AJCC v8 | Stadium IV Adenocarcinoom van de dunne darm AJCC v8 | Ampulla van Vater Adenocarcinoom | Stadium III... en andere voorwaardenVerenigde Staten
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University of UtahNational Cancer Institute (NCI)WervingVermoeidheid | Sedentaire levensstijl | Gemetastaseerd prostaatcarcinoom | Stadium IV prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVA prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVB prostaatkanker AJCC (American Joint Committee on Cancer) v8Verenigde Staten
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Zhuhai Beihai Biotech Co., LtdVoltooidVaste tumoren | Bio-equivalentie | DocetaxelIndië
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Jiangsu HengRui Medicine Co., Ltd.Shanghai Pulmonary Hospital, Shanghai, ChinaVoltooidNiet-kleincellige longkanker (NSCLC)China
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Arog Pharmaceuticals, Inc.IngetrokkenCarcinoom, niet-kleincellige long
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Australian and New Zealand Urogenital and Prostate...Peter MacCallum Cancer Centre, AustraliaWervingCastratieresistente prostaatkankerAustralië
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SanofiVoltooid
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SanofiVoltooidLongneoplasmataFrankrijk, Nederland, Spanje, Kalkoen, België, Finland, Italië, Verenigd Koninkrijk