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Using Positron Emission Tomography to Evaluate the Effects of Bevacizumab on Intra-tumoral Pharmacokinetics of 5-fluorouracil in Metastatic Colorectal Cancer

30. oktober 2009 opdateret af: Dana-Farber Cancer Institute
The purpose of this study is to investigate whether bevacizumab helps 5-Fluorouracil (5-FU) be delivered to the tumor more efficiently. Bevacizumab has been shown to inhibit the formation of new blood vessels in tumors and works best in combination with drugs that require blood vessels for transportation. Based on other experiments, bevacizumab may work by improving the transportation of other drugs to the tumor.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  • This is not a treatment study. A treatment regimen has already been decided upon by the patient and doctor.
  • At the screening visit for this trial the following will be performed: a medical history, physical examination, CT scan to measure the amount and size of the tumor(s), and a PET scan using glucose that has been attached to a small amount of radioactivity to determine how well the tumor takes up glucose.
  • Patients will then be randomized into one of 2 treatment groups. Group 1 will receive both 5-FU and bevacizumab on the first day of chemotherapy. Group 2 will receive just 5-FU on the first day of chemotherapy.
  • Patients will undergo a PET scan that uses water that has been attached to a small amount of radioactivity to measure how well the tumor takes up water prior to the 5-FU adminstration.
  • After patients receive 5-Fu they will undergo a PET scan during which a small amount of 5-FU has been attached to a small amount of radioactivity to measure how well the tumor takes up 5-FU.

Undersøgelsestype

Interventionel

Tilmelding

20

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
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Forenede Stater, 02115
        • Massachusetts General Hospital

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:

  • Metastatic colorectal cancer subjects
  • Subjects must have at least one non-radiated FDG-glucose avid (as demonstrated by an FDG-glucose PET scan) liver metastasis of at least 2 cm in size.
  • Subjects must have never received chemotherapy for metastatic disease; subjects may have received adjuvant chemotherapy for presumed early stage disease if it was completed at least 12 months prior to study entry date
  • All subjects must have already consented to an on-label use of a BV and fluorouracil containing first-line chemotherapy regimen (either with irinotecan or oxaliplatin) and must be a candidate for such a therapy as defined by the enrolling investigator and the community standard of care. As such a chemotherapy regimen requires an infusion port, this port should be placed at least two weeks prior to the subject's first dose of bevacizumab.
  • Chronological age ≥ 18 years.
  • ECOG performance status ≤ 2.
  • Life expectancy ≥ 12 weeks.
  • Women must not be pregnant or lactating. Both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study.
  • Subjects with concurrent malignancy of any site are eligible if the disease is under adequate control.
  • All subjects must sign informed consent.

Exclusion Criteria:

  • Subjects in "visceral crises", meaning a delay in achieving tumor response by 2 weeks may result in organ failure, are ineligible for this study.
  • Subjects who are planned to undergo treatment with fluorouracil and bevacizumab alone (without irinotecan or oxaliplatin) are ineligible for this trial.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
To compare the percent change in tumor radioactivity uptake and retention after radiolabeled fluorouracil administration in subjects who receive bevacizumab versus those who do not receive bevacizumab.

Sekundære resultatmål

Resultatmål
To compare the percent change in tumor flow induced by bevacizumab and fluorouracil
to evaluate the relationship between initial change in tumor radioactivity uptake and retention.

Samarbejdspartnere og efterforskere

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

Sponsor

Dana-Farber Cancer Institute

Samarbejdspartnere

Massachusetts General Hospital
Brigham and Women's Hospital

Efterforskere

  • Ledende efterforsker: David Ryan, MD, Massachusetts General Hospital

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. juli 2005

Studieafslutning (Faktiske)

1. oktober 2006

Datoer for studieregistrering

Først indsendt

12. september 2005

Først indsendt, der opfyldte QC-kriterier

12. september 2005

Først opslået (Skøn)

14. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. november 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2009

Sidst verificeret

1. oktober 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 04-415

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 .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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