Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction

7. oktober 2013 opdateret af: National Cancer Institute (NCI)

A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma

Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help cisplatin kill more cancer cells by making them more sensitive to the drug. This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction.

Studieoversigt

Detaljeret beskrivelse

PRIMARY OBJECTIVES:

I. Determine the objective response rate in patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with 3-AP (Triapine) and cisplatin.

SECONDARY OBJECTIVES:

I. Determine the toxicity of this regimen in these patients. II. Determine the duration of response and overall survival of patients treated with this regimen.

III. Determine the palliative benefits with regard to dysphagia in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive 3-AP (Triapine) IV over 2 hours on days 1-4. Patients also receive cisplatin IV over 60 minutes on days 2 and 3 before 3-AP infusion. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for up to 2 years.

PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 20 months.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

39

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637-1470
        • University of Chicago Comprehensive Cancer Center

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:

  • Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction

    • Metastatic or recurrent disease
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
    • Outside prior irradiation port
  • No known brain metastases
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 50-100%
  • More than 6 months
  • Absolute neutrophil count ≥ 1,500/mm^3
  • WBC ≥ 3,000/mm ^3
  • Platelet count ≥ 100,000/mm^3
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Bilirubin normal
  • Creatine normal
  • Creatinine clearance ≥ 50 mL/min
  • No prior myocardial infarction
  • No unstable angina
  • No cardiac arrhythmia
  • No uncontrolled congestive heart failure
  • No pulmonary disease requiring supplemental oxygen
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No glucose-6-phosphate dehydrogenase (G6PD) deficiency (for patients of African, Asian, or Mediterranean origin)
  • No other concurrent uncontrolled illness
  • No active or ongoing infection
  • No active second malignancy
  • No prior allergic reaction to compounds of similar chemical or biological composition to 3-AP or other study agents
  • No psychiatric illness or social situation that would preclude study compliance
  • At least 1 year since prior platinum-derivative agents
  • No prior chemotherapy for metastatic or recurrent esophageal cancer
  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy and recovered
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients

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
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment (triapine and cisplatin)
Patients receive 3-AP (Triapine) IV over 2 hours on days 1-4. Patients also receive cisplatin IV over 60 minutes on days 2 and 3 before 3-AP infusion. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Givet IV
Givet IV

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete response rate
Tidsramme: Up to 2 years
Will be calculated together with 95% confidence intervals based on the binomial distribution.
Up to 2 years
Objective response rate (CR + PR)
Tidsramme: Up to 2 years
Will be calculated together with 95% confidence intervals based on the binomial distribution.
Up to 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Samlet overlevelse
Tidsramme: Op til 2 år
Kaplan-Meier estimater vil blive fastlagt.
Op til 2 år
Progression-free survival
Tidsramme: From the start of treatment to progression or death, assessed up to 2 years
Kaplan-Meier estimates will be determined.
From the start of treatment to progression or death, assessed up to 2 years
Duration of response
Tidsramme: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years
From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years
Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0
Tidsramme: Up to 2 years
Up to 2 years
Number of patients with improvement of dysphagia
Tidsramme: Up to 2 years
Up to 2 years
Duration of improvement of dysphagia
Tidsramme: Up to 2 years
Up to 2 years

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Ann Mauer, University of Chicago Comprehensive Cancer Center

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. januar 2004

Primær færdiggørelse (Faktiske)

1. marts 2007

Datoer for studieregistrering

Først indsendt

10. februar 2004

Først indsendt, der opfyldte QC-kriterier

11. februar 2004

Først opslået (Skøn)

12. februar 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. oktober 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. oktober 2013

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • NCI-2012-02576 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • N01CM62201 (U.S. NIH-bevilling/kontrakt)
  • CDR0000352307
  • UCCRC-12765A
  • NCI-6285
  • 12765A (Anden identifikator: University of Chicago Comprehensive Cancer Center)
  • 6285 (Anden identifikator: CTEP)

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 i spiserøret

Kliniske forsøg med triapin

Abonner