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Tezacitabine With or Without 5-Fluorouracil (5-FU) for Advanced Esophageal Cancer or Gastric Cancer

10. juli 2006 opdateret af: Chiron Corporation
The purpose of this study is to evaluate the efficacy and safety of tezacitabine when given alone or in combination with 5-fluorouracil (5-FU) to subjects who have advanced esophageal or gastric adenocarcinoma.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85712
        • ACRC/Arizona Clinical Research Center
    • California
      • Glendale, California, Forenede Stater, 91204
        • Glendale Memorial Hospital
      • Los Angeles, California, Forenede Stater, 90033
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, Forenede Stater, 90048
        • Tower Hematology Oncology Medical Group
      • Palm Springs, California, Forenede Stater, 92262
        • Desert Regional Medical Center
      • Palm Springs, California, Forenede Stater, 92262
        • Comprehensive Cancer Center at DRMC
      • San Diego, California, Forenede Stater, 92123
        • Sharp Clinical Oncology Research
      • San Francisco, California, Forenede Stater, 94115-1705
        • UCSF Comprehensive Cancer Center
      • Santa Monica, California, Forenede Stater, 90404
        • Cancer Institute Medical Group
    • Colorado
      • Denver, Colorado, Forenede Stater, 80220
        • Denver VAMC
    • Florida
      • Tampa, Florida, Forenede Stater, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
      • Weston, Florida, Forenede Stater, 33326
        • Memorial Regional Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • The University of Chicago
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University, Feinberg School of Medicine, Division of Hematology/Oncology
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Clinic Foundation
      • Shreveport, Louisiana, Forenede Stater, 77130
        • LSU Health Sciences Center, Dept. of Medicine, Hematology/Oncology
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-0922
        • University of Michigan Medical Center
      • Detroit, Michigan, Forenede Stater, 48202
        • Josephine Ford Cancer Center, Henry Ford Health System
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Kansas City Oncology and Hematology Group
      • St. Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19111
        • Fox Chase Cancer Center
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, Forenede Stater, 37203
        • The Sarah Cannon Cancer Center, Tennessee Oncology
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • University of Texas, MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Swedish Cancer Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Males and females greater than or equal to 18 years of age.
  • Histologically confirmed recurrent (inoperable) or metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or stomach.
  • At least one bidimensionally measurable lesion, not previously irradiated, with a diameter that meets RECIST criteria, that can be serially measured. Intraluminal tumors, evaluable only by endoscopy, are not acceptable as target lesions.
  • Karnofsky Performance Score greater than or equal to 70%.
  • Subjects must be in the second line therapy setting, thus they must have experienced progression following treatment with one (and only one) prior chemotherapy regimen used for the treatment of unresectable locally advanced, recurrent, or metastatic disease.
  • Recovery from any serious (grade 3 or higher) toxic effects of prior radiation therapy.
  • Adequate hematologic profile: absolute neutrophil count greater than or equal to 1,500/mm3; hemoglobin greater than or equal to 9 g/dL; hematocrit greater than or equal to 30% (transfusion allowed); and platelet count greater than or equal to 100,000/mm3.
  • Adequate hepatic function: bilirubin less than or equal to 1.5 mg/dL; AST and ALT less that 2.5 X ULN (5 X ULN if liver involved with tumor); alkaline phosphatase less than 5 X ULN
  • Adequate renal function; serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than 50 mL/min.
  • Both male and female subjects of childbearing potential must be using a contraceptive method that is medically acceptable to the investigative center.
  • Disease-free from a prior malignancy, other than non-melanoma skin cancer or carcinoma in-situ of the cervix, for greater than 5 years.

Exclusion Criteria:

  • Unstable angina or class III or IV New York Heart Association heart disease.
  • CNS metastases.
  • Pregnant or breast-feeding.
  • Uncontrolled seizure disorder.
  • Ongoing (grade 3 or higher) stomatitis, esophagopharyngitis, or uncontrolled diarrhea.
  • Impaired nutritional status as evidenced by a serum albumin of 2.7 mg/dL or less.
  • Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment. Concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chiron Corporation

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2003

Studieafslutning

1. december 2004

Datoer for studieregistrering

Først indsendt

12. februar 2003

Først indsendt, der opfyldte QC-kriterier

12. februar 2003

Først opslået (Skøn)

13. februar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. juli 2006

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juli 2006

Sidst verificeret

1. juni 2006

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TEZ001

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Adenocarcinom

Kliniske forsøg med 5-fluoruracil

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Japan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner