Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy
1. juli 2016 oppdatert av: Alliance for Clinical Trials in Oncology
A Pharmacogenetic Case-Control Study of Severe Diarrhea and Life-Threatening Neutropenia in Patients Treated With Irinotecan, 5-Fluorouracil and Leucovorin
RATIONALE: Genetic testing may help predict how patients will respond to chemotherapy drugs and may help doctors plan more effective treatment with fewer side effects.
PURPOSE: Genetic study to determine how genes affect the severity of diarrhea in patients with stage III colon cancer who are receiving chemotherapy.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Determine whether the presence of a 7 allele at the UGT1A1 locus is associated with either grade 3-4 diarrhea or grade 4 neutropenia in patients with stage III colon cancer after treatment with irinotecan, fluorouracil, and leucovorin calcium.
- Determine whether polymorphisms in the TS enhancer and/or MTHFR gene are associated with grade 3-4 diarrhea in these patients after treatment with fluorouracil and leucovorin calcium.
- Determine whether polymorphisms in UGT1A1, TS, MTHFR, CYP3A4, or CYP3A5 are associated with either grade 3-4 diarrhea or grade 4 neutropenia in these patients after treatment with irinotecan, fluorouracil, and leucovorin calcium.
OUTLINE: Patients are stratified according to prior therapy (irinotecan, fluorouracil, and leucovorin calcium vs fluorouracil and leucovorin calcium) and prior toxic effects (grade 3-4 diarrhea vs grade 4 neutropenia vs grade 1 or lower diarrhea AND grade 2 or lower neutropenia).
Patients undergo collection of blood specimens for polymerase chain reaction and restriction fragment length polymorphism analysis. Genotyping assays are performed to determine UGT1A1 promoter genotyping, UGT1A1 coding polymorphisms, TS promoter polymorphisms, and MTHFR polymorphisms.
Studietype
Observasjonsmessig
Registrering (Faktiske)
308
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Quebec
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Montreal, Quebec, Canada, H2W 1S6
- McGill University
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Alabama
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Anniston, Alabama, Forente stater, 36207
- Northeast Alabama Regional Medical Center
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California
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La Jolla, California, Forente stater, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Los Angeles, California, Forente stater, 90048
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
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San Diego, California, Forente stater, 92161
- Veterans Affairs Medical Center - San Diego
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San Francisco, California, Forente stater, 94115
- UCSF Comprehensive Cancer Center
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San Francisco, California, Forente stater, 94121
- Veterans Affairs Medical Center - San Francisco
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Delaware
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Newark, Delaware, Forente stater, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Forente stater, 20007
- Lombardi Cancer Center of Georgetown University Medical Center
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Washington, District of Columbia, Forente stater, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, Forente stater, 20422
- Veterans Affairs Medical Center - Washington, DC
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Florida
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Fort Lauderdale, Florida, Forente stater, 33316
- Broward General Medical Center
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Hollywood, Florida, Forente stater, 33021
- Memorial Regional Hospital Comprehensive Cancer Center
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Miami Beach, Florida, Forente stater, 33140
- CCOP - Mount Sinai Medical Center
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Orlando, Florida, Forente stater, 32804
- Florida Hospital Cancer Institute
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West Palm Beach, Florida, Forente stater, 33401
- Palm Beach Cancer Institute
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Illinois
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Chicago, Illinois, Forente stater, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, Forente stater, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, Forente stater, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Forente stater, 60640
- Louis A. Weiss Memorial Hospital
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River Forest, Illinois, Forente stater, 60305
- West Suburban Center for Cancer Care
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Rockford, Illinois, Forente stater, 61108
- Saint Anthony Medical Center
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Indiana
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Fort Wayne, Indiana, Forente stater, 46885-5099
- Fort Wayne Medical Oncology and Hematology, Incorporated
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South Bend, Indiana, Forente stater, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Iowa City, Iowa, Forente stater, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Louisville, Kentucky, Forente stater, 40207
- Baptist Hospital East - Louisville
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
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Baltimore, Maryland, Forente stater, 21201
- Veterans Affairs Medical Center - Baltimore
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Worcester, Massachusetts, Forente stater, 01655
- University of Massachusetts Memorial Medical Center - University Campus
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Michigan
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Saint Joseph, Michigan, Forente stater, 49085
- Lakeland Medical Center - St. Joseph
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, Forente stater, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, Forente stater, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, Forente stater, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Saint Louis, Missouri, Forente stater, 63110
- Barnes-Jewish Hospital
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Saint Louis, Missouri, Forente stater, 63110
- Siteman Cancer Center
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Saint Louis, Missouri, Forente stater, 63131
- Missouri Baptist Cancer Center
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Nebraska
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Omaha, Nebraska, Forente stater, 68198-7680
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Forente stater, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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Las Vegas, Nevada, Forente stater, 89106
- Veterans Affairs Medical Center - Las Vegas
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756-0002
- Norris Cotton Cancer Center at Dartmouth Medical School
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New Jersey
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Camden, New Jersey, Forente stater, 08103
- Cooper University Hospital
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New York
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Buffalo, New York, Forente stater, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, Forente stater, 14215
- Veterans Affairs Medical Center - Buffalo
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Elmhurst, New York, Forente stater, 11373
- Elmhurst Hospital Center
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Jamaica, New York, Forente stater, 11432
- Queens Cancer Center of Queens Hospital
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Manhasset, New York, Forente stater, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Forente stater, 11030
- North Shore University Hospital
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New York, New York, Forente stater, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Forente stater, 10029
- Mount Sinai Medical Center, NY
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New York, New York, Forente stater, 10021
- New York Weill Cornell Cancer Center at Cornell University
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Syracuse, New York, Forente stater, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, Forente stater, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, Forente stater, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Asheville, North Carolina, Forente stater, 28805
- Veterans Affairs Medical Center - Asheville
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Chapel Hill, North Carolina, Forente stater, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Concord, North Carolina, Forente stater, 28025
- NorthEast Oncology Associates
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Durham, North Carolina, Forente stater, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, Forente stater, 27710
- Duke Comprehensive Cancer Center
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Fayetteville, North Carolina, Forente stater, 28302-2000
- Cape Fear Valley Health System
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Kinston, North Carolina, Forente stater, 28503-1678
- Lenoir Memorial Hospital Cancer Center
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Pinehurst, North Carolina, Forente stater, 28374
- Firsthealth Moore Regional Hospital
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Wilmington, North Carolina, Forente stater, 28402-9025
- New Hanover Regional Medical Center
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Winston-Salem, North Carolina, Forente stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Forente stater, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Fargo, North Dakota, Forente stater, 58102
- Veterans Affairs Medical Center - Fargo
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Ohio
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Columbus, Ohio, Forente stater, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Pennsylvania
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Danville, Pennsylvania, Forente stater, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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Pittsburgh, Pennsylvania, Forente stater, 15224
- Western Pennsylvania Hospital
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Rhode Island
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Providence, Rhode Island, Forente stater, 02906
- Lifespan: The Miriam Hospital
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Texas
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Dallas, Texas, Forente stater, 75216
- Veterans Affairs Medical Center - Dallas
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Dallas, Texas, Forente stater, 75235-9154
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas
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Vermont
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Bennington, Vermont, Forente stater, 05201
- Green Mountain Oncology Group
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Burlington, Vermont, Forente stater, 05401-3498
- Vermont Cancer Center at University of Vermont
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White River Junction, Vermont, Forente stater, 05009
- Veterans Affairs Medical Center - White River Junction
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Virginia
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Charlottesville, Virginia, Forente stater, 22902
- Martha Jefferson Hospital
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Norfolk, Virginia, Forente stater, 23502
- Virginia Oncology Associates - Norfolk
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Richmond, Virginia, Forente stater, 23298-0037
- MBCCOP - Massey Cancer Center
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Roanoke, Virginia, Forente stater, 24014
- Oncology and Hematology Associates of Southwest Virginia, Inc.
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West Virginia
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Huntington, West Virginia, Forente stater, 25701
- St. Mary's Medical Center
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Wisconsin
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Green Bay, Wisconsin, Forente stater, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Rhinelander, Wisconsin, Forente stater, 54501
- Ministry Medical Group - Northern Region
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San Juan, Puerto Rico, 00936-5067
- University of Puerto Rico School of Medicine Medical Sciences Campus
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients diagnosed with adenocarcinoma of the colon and previously enrolled on CALGB-89803.
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically confirmed stage III adenocarcinoma of the colon
Enrolled on CALGB-89803 and must fall into 1 of the following categories:
Received irinotecan, fluorouracil, and leucovorin calcium and experienced at least 1 of the following:
- Grade 3-4 diarrhea
- Grade 4 neutropenia
- Grade 1 or lower diarrhea AND grade 2 or lower neutropenia
Received fluorouracil and leucovorin calcium and experienced at least 1 of the following:
- Grade 3-4 diarrhea
- Grade 1 or lower diarrhea AND grade 2 or lower neutropenia
PATIENT CHARACTERISTICS:
Age
- 18 and over
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Group 1
Patients undergo collection of blood specimens for polymerase chain reaction and restriction fragment length polymorphism analysis.
Genotyping assays are performed to determine UGT1A1 promoter genotyping, UGT1A1 coding polymorphisms, TS promoter polymorphisms, and MTHFR polymorphisms.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
response
Tidsramme: Up to 4 years
|
Up to 4 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Studiestol: Mark J. Ratain, MD, University of Chicago
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2002
Primær fullføring (Faktiske)
1. november 2006
Studiet fullført (Faktiske)
1. november 2006
Datoer for studieregistrering
Først innsendt
12. november 2002
Først innsendt som oppfylte QC-kriteriene
26. januar 2003
Først lagt ut (Anslag)
27. januar 2003
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. juli 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juli 2016
Sist bekreftet
1. juli 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CALGB-60102
- NCCTG-CALGB-60102
- CDR0000257145 (Registeridentifikator: NCI Physician Data Query)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .