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- Klinische proef NCT00004242
Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
Phase I Study of Oxaliplatin in Combination With 5-Fluorouracil and Gemcitabine in Patients With Solid Tumors
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES:
I. Determine the maximum tolerated dose, recommended phase II dose, and associated toxic effects of the triple combination of continuous infusion fluorouracil, weekly gemcitabine, and oxaliplatin in patients with metastatic or unresectable solid tumors.
II. Define sequence dependent toxic effects, if any, and establish pharmacokinetic and pharmacodynamic relationships in context of this triple combination chemotherapy in this patient population.
OUTLINE: This is a dose-escalation study of oxaliplatin and gemcitabine.
For course 1, and then course 3 and beyond, patients receive oxaliplatin IV over 2 hours on day 1, followed by gemcitabine IV over 30 minutes on days 1 and 8, and then fluorouracil IV continuously on days 1-14. For course 2, patients receive treatment in the same manner as in course 1, except gemcitabine is given initially, followed by oxaliplatin, and then fluorouracil. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 1-6 patients receive escalating doses of oxaliplatin and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. The recommended phase II dose (RPTD) is defined as the dose preceding MTD.
Once RPTD is defined, the cohort is expanded to an additional 13 patients. These patients receive a fixed dose of oxaliplatin, gemcitabine, and fluorouracil as determined by the phase I dose escalation portion of this study.
Patients are followed for disease progression.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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New York
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Bronx, New York, Verenigde Staten, 10461
- Albert Einstein Comprehensive Cancer Center
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New York, New York, Verenigde Staten, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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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:
- Histologically or clinically confirmed metastatic or unresectable solid tumor for which no standard curative or palliative therapy exists or is no longer
- No known brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin normal
- Proven Gilbert's syndrome (UGT1A1 promoter mutation or clinical
- documentation of stress bilirubin levels) allowed
- AST/ALT no greater than 3 times upper limit of normal
Renal:
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Pulmonary:
- No unexplained respiratory problems (e.g., nonproductive cough, dyspnea,
- rales, pulmonary infiltrates, hypoxia, or tachypnea)
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No clinical evidence of neuropathy
- No prior allergy to platinum compounds
- No prior allergy to antiemetics appropriate for administration in
- conjunction with protocol directed chemotherapy
- No other concurrent uncontrolled illness (e.g., active infection)
PRIOR CONCURRENT THERAPY:
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and
- platinum) and recovered
- No more than 1 prior chemotherapy regimen for cancer
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Other:
- No concurrent antiretroviral agents (HAART)
- No other concurrent investigational agents or commercial therapies
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Arm ik
Zie gedetailleerde beschrijving.
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- Basu S, Goel S, Hochster H, et al.: Phase I and pharmacokinetic (PK) study of oxaliplatin (Ox) with gemcitabine (Gem) and continuous intravenous (CIV) infusion 5-fluorouracil (FU) in patients with advanced solid malignancies. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2132, 2002.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire 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
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Enzymremmers
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Gemcitabine
- Fluoruracil
- Oxaliplatine
Andere studie-ID-nummers
- CDR0000067487
- AECM-1199904138
- NCI-T99-0023
- NYU-9944
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 .
Klinische onderzoeken op fluoruracil
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Peking Union Medical College HospitalWervingRectale kanker | Darmkanker | Chemotherapie-effect | PTC | Exon-mutatieChina
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Sun Yat-sen UniversityZhejiang Cancer Hospital; Fudan University; Peking University Cancer Hospital &... en andere medewerkersOnbekendNasofarynxcarcinoomChina
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CStone PharmaceuticalsActief, niet wervendInoperabel lokaal gevorderd, recidiverend of gemetastaseerd slokdarmplaveiselcelcarcinoomChina
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Actavis Inc.VoltooidActinische keratoseVerenigde Staten
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The Netherlands Cancer InstituteVoltooid
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Encube Ethicals Pvt. Ltd.CBCC Global ResearchVoltooid
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Hong Kong Nasopharyngeal Cancer Study Group LimitedThe Hong Kong Anti-Cancer Society; hong Kong Cancer FundVoltooid
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Boston UniversityWervingOppervlakkig basaalcelcarcinoom | Plaveiselcelcarcinoom in situVerenigde Staten
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The Cleveland ClinicNational Cancer Institute (NCI)BeëindigdActinische keratose | Orgaan- of weefseltransplantatie; complicatiesVerenigde Staten
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Singapore National Eye CentreSingapore Eye Research Institute; Nanchang UniversityVoltooidGlaucoom | Wond genezen | TrabeculectomieSingapore