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Celecoxib in Treating Patients With Early-Stage Rectal Cancer

2. marts 2013 opdateret af: A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center

Pilot COX-2 Activity in Early Stage Rectal Cancer -Short Term Administration of Celecoxib (SPORE)

RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how rectal cancer will respond to treatment with celecoxib.

PURPOSE: This clinical trial is studying how well celecoxib works in treating patients with early-stage rectal cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Determine cyclooxygenase-2 (COX-2) over-expression in tumor specimens from patients with early-stage rectal cancer.
  • Determine whether administration of a COX-2 inhibitor, celecoxib, results in changes in tumor (COX-2 overexpressing) levels of eicosanoids but not in levels in the surrounding normal tissue that is expected not to express COX-2.
  • Determine whether surrogate markers of eicosanoid metabolism (i.e., serum VEGF levels, tumor prostaglandin E_2 [PGE_2], and the major urinary metabolite of PGE_2 [PGE-M]) in biological specimens from these patients correlate with changes noted in tumor tissue.
  • Determine if there is a greater change in protein and gene expression from pretreatment biopsy levels in patient tumor specimens (COX-2 overexpressing) vs specimens of surrounding normal tissue (expected not to be COX-2 overexpressing).

OUTLINE: Patients receive oral celecoxib twice daily on days 1-5. Patients then undergo planned local excision or definitive radical resection on day 6.

Tumor tissue and normal tissue (at least 5 cm away from the tumor) samples are collected pretreatment. Post-treatment tissue samples are collected along with the surgery. Serum and urine samples are obtained at baseline and after administration of celecoxib. Tumor and normal tissue specimens are analyzed by assays measuring markers of cyclooxygenase-2 (COX-2) activity (i.e., COX-2 mRNA and protein, tumor prostaglandin E_2 [PGE_2], and VEGF). Tissue samples are also assessed by cDNA microarray and imaging mass spectrometry to determine overall changes in gene and protein expression from pretreatment levels. Surrogate markers of COX-2 activity in serum (i.e., VEGF) and urine (i.e., urinary metabolite of PGE_2 [PGE-M]) are also assessed and compared with changes noted in tumor tissue. COX-2 protein levels are determined by immunohistochemistry in patients with limited pretreatment tumor tissue specimens.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, Forenede Stater, 37212
        • Veterans Administration

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:

  • Clinical diagnosis of primary adenocarcinoma of the rectum (to be histologically confirmed upon study entry)

    • Tumor must be at or below the peritoneal reflection
    • The distal border of the tumor is within 12 cm of the anal verge on proctoscopic examination
  • Clinically resectable disease

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • WBC ≥ 4,000/mm³
  • Platelet count ≥ 150,000/mm³
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other serious medical illness (other than rectal cancer) that would preclude study therapy
  • No psychiatric condition that would preclude informed consent
  • No history of allergy to celecoxib or any other NSAIDs, including acetylsalicylic acid (i.e., aspirin), ibuprofen, or indomethacin
  • No history of allergy to sulfonamides

Exclusion criteria:

Not noted

PRIOR CONCURRENT THERAPY:

  • At least 7 days since prior and no concurrent NSAIDs or other cyclooxygenase-2 inhibitors
  • No concurrent warfarin, except low-dose warfarin (i.e., 1 mg/day) administered for prophylaxis

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: Therapeutic Intervention/Celecoxib
Celecoxib
Andet: massespektrometri
Andet: immunhistokemi farvningsmetode
ikke noteret
Andet: laboratoriebiomarkøranalyse
ikke noteret
Medicin: celecoxib
Will be administered orally 400 mg po BID starting 5 days prior to planned surgical resection.
Andre navne:
  • Celebrex
Genetisk: gene expression analysis
not noted
Genetisk: protein expression analysis
Not noted
Procedure: biopsy
At the time of preoperative evaluation by surgeon as well as one week after administration of Celecoxib.
Procedure: neoadjuvant therapy
not noted
Procedure: therapeutic conventional surgery
not noted

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Event rate of over-expression of cyclooxygenase-2
Tidsramme: Pre and post 7 days administration of study drug
Pre and post 7 days administration of study drug
Percent change of eicosanoid level
Tidsramme: Pre and post celecoxib treatment ratio of eicosanoid production
Pre and post celecoxib treatment ratio of eicosanoid production
Percent change of VEGF and prostaglandin-M levels
Tidsramme: Pre and post celecoxib treatment VEGF and PGE-M levels
Pre and post celecoxib treatment VEGF and PGE-M levels
Change of gene and protein expression pattern from pre- to post-treatment levels
Tidsramme: Pre and post celecoxib treatment
Pre and post celecoxib treatment

Samarbejdspartnere og efterforskere

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

Sponsor

Vanderbilt-Ingram Cancer Center

Samarbejdspartnere

National Cancer Institute (NCI)

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 2002

Primær færdiggørelse (Faktiske)

1. maj 2004

Studieafslutning (Faktiske)

1. april 2008

Datoer for studieregistrering

Først indsendt

30. januar 2008

Først indsendt, der opfyldte QC-kriterier

2. februar 2008

Først opslået (Skøn)

6. februar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. marts 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. marts 2013

Sidst verificeret

1. marts 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VICC GI 0174
  • VU-VICC-GI-0174

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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