- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
New York
-
Bronx, New York, Forente stater, 10461
- Albert Einstein Comprehensive Cancer Center
-
New York, New York, Forente stater, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Arm I
Se detaljert beskrivelse.
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gemcitabin
- Fluorouracil
- Oksaliplatin
Andre studie-ID-numre
- CDR0000067487
- AECM-1199904138
- NCI-T99-0023
- NYU-9944
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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