- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00020488
Combination Chemotherapy in Treating Patients Who Have Advanced Solid Tumors
A Phase I & Pharmacologic Trial Of Sequential Irinotecan As A 24-Hour IV Infusion, Leucovorin, & Flurouracil As A 48-Hour IV Infusion In Adult Cancer Patients
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
- Determine the recommended phase II dose of irinotecan, leucovorin calcium, and fluorouracil in patients with advanced solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetic and pharmacodynamic profiles of irinotecan and fluorouracil in patients treated with this regimen.
- Determine the correlation of polymorphisms in the promoter region of the thymidylate synthase gene with clinical toxicity and response in patients treated with this regimen.
- Determine the correlation of polymorphisms in the uridine diphosphate glucuronosyltransferase 1A1 gene promoter with the extent of SN-38 glucuronidation and severity of diarrhea in patients treated with this regimen.
- Assess any anti-tumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of irinotecan and fluorouracil.
Patients receive irinotecan IV continuously over 24 hours on days 1 and 15 and leucovorin calcium IV over 30 minutes followed by fluorouracil IV continuously over 48 hours on days 2 and 16. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. Once the MTD of irinotecan has been determined, additional cohorts receive escalating doses of fluorouracil until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study within 20 months.
Tipo di studio
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Maryland
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Bethesda, Maryland, Stati Uniti, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
Histologically confirmed advanced solid tumor that has failed standard therapy or for which no standard therapy exists
- Locally advanced, unresectable, primary or recurrent disease OR
- Metastatic disease
- Previously untreated disease allowed provided this regimen represents reasonable first-line therapy
- No leukemia or lymphoma
- No primary CNS malignancy or CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.6 mg/dL
- AST/ALT no greater than 4 times upper limit of normal
Renal:
- Creatinine no greater than 1.6 mg/dL
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No other serious concurrent illness that would preclude study
- No active infection requiring IV antibiotics
- No known hypersensitivity to irinotecan
- No marked intolerance to fluorouracil
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- More than 4 weeks since prior immunotherapy and recovered
Chemotherapy:
- More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered
- Prior short-infusion irinotecan allowed
- Prior fluorouracil allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 2 weeks since prior radiotherapy and recovered
- At least 8 weeks since prior strontium chloride Sr 89
Surgery:
- Recovered from prior surgery
Other:
- No concurrent cimetidine
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Eva Szabo, MD, National Cancer Institute (NCI)
Studiare le date dei record
Studia le date principali
Inizio studio
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
Termini MeSH pertinenti aggiuntivi
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti protettivi
- Inibitori della topoisomerasi
- Micronutrienti
- Vitamine
- Ormoni e agenti regolatori del calcio
- Inibitori della topoisomerasi I
- Antidoti
- Complesso di vitamina B
- Fluorouracile
- Leucovorin
- Irinotecano
- Calcio
- Levoleucovorin
Altri numeri di identificazione dello studio
- CDR0000068548
- NCI-01-C-0082
- MB-NAVY-00-02
- MB-NAVY-B00-038
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 .
Prove cliniche su fluorouracile
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SanofiCompletatoNeoplasie della testa e del colloCina
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University Hospital of CreteCompletatoCancro colorettale metastaticoGrecia
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Encube Ethicals Pvt. Ltd.CBCC Global ResearchCompletato
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M.D. Anderson Cancer CenterReclutamentoMetastasi epaticheStati Uniti