Celecoxib in Treating Patients With Early-Stage Rectal Cancer
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
- Sonstiges: Massenspektrometer
- Sonstiges: immunhistochemische Färbemethode
- Sonstiges: Labor-Biomarker-Analyse
- Arzneimittel: celecoxib
- Genetisch: gene expression analysis
- Genetisch: protein expression analysis
- Verfahren: biopsy
- Verfahren: neoadjuvant therapy
- Verfahren: therapeutic conventional surgery
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Tennessee
-
Nashville, Tennessee, Vereinigte Staaten, 37232
- Vanderbilt-Ingram Cancer Center
-
Nashville, Tennessee, Vereinigte Staaten, 37212
- Veterans Administration
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Therapeutic Intervention/Celecoxib
Celecoxib
|
nicht notiert
nicht notiert
Will be administered orally 400 mg po BID starting 5 days prior to planned surgical resection.
Andere Namen:
not noted
Not noted
At the time of preoperative evaluation by surgeon as well as one week after administration of Celecoxib.
not noted
not noted
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Event rate of over-expression of cyclooxygenase-2
Zeitfenster: Pre and post 7 days administration of study drug
|
Pre and post 7 days administration of study drug
|
|
Percent change of eicosanoid level
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Pre and post celecoxib treatment
|
Pre and post celecoxib treatment
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen
- Neubildungen nach Standort
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Darmerkrankungen
- Darmtumoren
- Rektale Erkrankungen
- Kolorektale Neubildungen
- Rektale Neoplasien
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Agenten des peripheren Nervensystems
- Enzym-Inhibitoren
- Analgetika
- Agenten des sensorischen Systems
- Entzündungshemmende Mittel, nichtsteroidal
- Analgetika, nicht narkotisch
- Entzündungshemmende Mittel
- Antirheumatika
- Cyclooxygenase-Inhibitoren
- Cyclooxygenase-2-Inhibitoren
- Celecoxib
Andere Studien-ID-Nummern
- VICC GI 0174
- VU-VICC-GI-0174
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