- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
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Illinois
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Chicago, Illinois, Stati Uniti, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Evanston, Illinois, Stati Uniti, 60201
- Evanston Northwestern Health Care - Evanston Hospital
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Joliet, Illinois, Stati Uniti, 60432
- Silver Cross Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Athanassios Argiris, MD, Robert H. Lurie Cancer Center
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Neoplasie polmonari
- Carcinoma, polmone non a piccole cellule
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti del sistema nervoso periferico
- Inibitori enzimatici
- Analgesici
- Agenti del sistema sensoriale
- Agenti antinfiammatori, non steroidei
- Analgesici, non narcotici
- Agenti antinfiammatori
- Agenti antireumatici
- Inibitori della ciclossigenasi
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Inibitori della topoisomerasi
- Inibitori della cicloossigenasi 2
- Inibitori della topoisomerasi I
- Docetaxel
- Celecoxib
- Irinotecano
Altri numeri di identificazione dello studio
- NU 01L2
- NU-01L2
- PHARMACIA-NU-01L2
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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