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A Pharmacogenetic Case-Control Study of Severe Diarrhea and Life-Threatening Neutropenia in Patients Treated With Irinotecan, 5-Fluorouracil and Leucovorin


N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Diarrhea, Neutropenia

Thank you

Trial Information

A Pharmacogenetic Case-Control Study of Severe Diarrhea and Life-Threatening Neutropenia in Patients Treated With Irinotecan, 5-Fluorouracil and Leucovorin


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.

PROJECTED ACCRUAL: Approximately 308 patients will be accrued for this study.

Inclusion Criteria


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

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

Hepatic

- Not specified

Renal

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Mark J. Ratain, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

CDR0000257145

NCT ID:

NCT00048971

Start Date:

April 2002

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Diarrhea
  • Neutropenia
  • adenocarcinoma of the colon
  • stage III colon cancer
  • diarrhea
  • neutropenia
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Diarrhea
  • Neutropenia

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Barnes-Jewish HospitalSaint Louis, Missouri  63110
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Green Mountain Oncology GroupRutland, Vermont  05701
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Martha Jefferson HospitalCharlottesville, Virginia  22901
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Broward General Medical CenterFort Lauderdale, Florida  33316
Florida Hospital Cancer InstituteOrlando, Florida  32804
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer CenterHollywood, Florida  33021
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Saint Anthony Medical CenterRockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201
Lakeland Medical Center - St. JosephSaint Joseph, Michigan  49085
Veterans Affairs Medical Center - Las VegasLas Vegas, Nevada  89106
Cooper University HospitalCamden, New Jersey  08103
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
NorthEast Oncology AssociatesConcord, North Carolina  28025
Cape Fear Valley Health SystemFayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer CenterKinston, North Carolina  28503-1678
FirstHealth Moore Regional HospitalPinehurst, North Carolina  28374
New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
St. Mary's Medical CenterHuntington, West Virginia  25701
Ministry Medical Group - Northern RegionRhinelander, Wisconsin  54501
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California  90048
Norris Cotton Cancer Center at Dartmouth Medical SchoolLebanon, New Hampshire  03756-0002
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Siteman Cancer CenterSaint Louis, Missouri  63110
Lombardi Cancer Center of Georgetown University Medical CenterWashington, District of Columbia  20007
Simmons Cancer Center at University of Texas Southwestern Medical Center - DalasDallas, Texas  75235-9154