Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT00063141
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cetuximab — DRUG
    Vial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision
  • Irinotecan — DRUG
    Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
  • Irinotecan — DRUG
    Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision

Study Details

The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.

Key Dates

Start date
Apr 30, 2003
Status verified
Apr 2010
Primary completion
Jun 30, 2006
Completion
Oct 31, 2007

Study Design

Enrollment
1,302 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
  • Active Comparator: Arm B

Primary Outcome Measure

Overall Survival [ Time Frame: Every 3 months after subject off-treatment ]

Locations (116)

FacilityCityStateZIPSite coordinators
ImClone Investigational SiteTucsonArizona85712-
ImClone Investigational SitePine BluffArkansas71603-
ImClone Investigational SiteBakersfieldCalifornia93309-
ImClone Investigational SiteBerkeleyCalifornia94704-
ImClone Investigational SiteBeverly HillsCalifornia90211-
ImClone Investigational SiteCoronaCalifornia92708-
ImClone Investigational SiteGilroyCalifornia95020-
ImClone Investigational SiteGreenbraeCalifornia95904-
ImClone Investigational SiteLong BeachCalifornia90813-
ImClone Investigational SiteLos AngelesCalifornia90033-
ImClone Investigational SiteLos AngelesCalifornia90057-
ImClone Investigational SiteMontebelloCalifornia90640-
ImClone Investigational SiteOrangeCalifornia92868-
ImClone Investigational SitePalm SpringsCalifornia92262-
ImClone Investigational SiteRancho MirageCalifornia92270-
ImClone Investigational SiteSan DiegoCalifornia92120-
ImClone Investigational SiteStocktonCalifornia95204-
ImClone Investigational SiteVallejoCalifornia94589-
ImClone Investigational SiteAuroraColorado80012-
ImClone Investigational SiteDenverColorado80218-
ImClone Investigational SiteNew HavenConnecticut06520-
ImClone Investigational SiteNew LondonConnecticut06320-
ImClone Investigational SiteNorwichConnecticut06360-
ImClone Investigational SiteStamfordConnecticut06902-
ImClone Investigational SiteFort MyersFlorida33901-
ImClone Investigational SiteFort MyersFlorida33990-
ImClone Investigational SiteInvernessFlorida34452-
ImClone Investigational SiteJacksonvilleFlorida32207-
ImClone Investigational SiteJacksonvilleFlorida32209-
ImClone Investigational SiteJacksonvilleFlorida32224-
ImClone Investigational SiteLakelandFlorida33805-
ImClone Investigational SiteMiamiFlorida33136-
ImClone Investigational SiteNew Port RicheyFlorida34652-
ImClone Investigational SiteOrlandoFlorida32806-
ImClone Investigational SitePort Saint LucieFlorida34952-
ImClone Investigational SiteAtlantaGeorgia30309-
ImClone Investigational SiteAtlantaGeorgia30322-
ImClone Investigational SiteColumbusGeorgia31902-0951-
ImClone Investigational SiteMaconGeorgia31201-
ImClone Investigational SiteSavannahGeorgia31405-
ImClone Investigational SiteTuckerGeorgia30342-
ImClone Investigational SiteHonoluluHawaii96813-
ImClone Investigational SiteNapervilleIllinois60540-
ImClone Investigational SiteSouth BendIndiana46601-
ImClone Investigational SiteKansas CityKansas66160-
ImClone Investigational SiteOverland ParkKansas66214-
ImClone Investigational SiteLexingtonKentucky40536-0098-
ImClone Investigational SiteLouisvilleKentucky40202-
ImClone Investigational SiteRichmondKentucky40475-
ImClone Investigational SiteBaton RougeLouisiana70808-
ImClone Investigational SiteLafayetteLouisiana70506-
ImClone Investigational SiteMetairieLouisiana70006-
ImClone Investigational SiteShreveportLouisiana71103-
ImClone Investigational SiteBaltimoreMaryland21204-
ImClone Investigational SiteFrederickMaryland21701-
ImClone Investigational SiteBostonMassachusetts02135-
ImClone Investigational SiteAnn ArborMichigan48106-
ImClone Investigational SiteDetroitMichigan48201-
ImClone Investigational SiteSouthfieldMichigan48075-
ImClone Investigational SiteMinneapolisMinnesota55407-3799-
ImClone Investigational SiteRobbinsdaleMinnesota55422-
ImClone Investigational SiteSaint Louis ParkMinnesota55426-
ImClone Investigational SiteJacksonMississippi39202-
ImClone Investigational SiteKansas CityMissouri64111-
ImClone Investigational SiteRollaMissouri65401-
ImClone Investigational SiteSt LouisMissouri63110-
ImClone Investigational SiteTrentonNew Jersey08690-
ImClone Investigational SiteVoorhees TownshipNew Jersey08084-
ImClone Investigational SiteAlbanyNew York12208-
ImClone Investigational SiteEast SetauketNew York11733-
ImClone Investigational SiteLathamNew York12110-
ImClone Investigational SiteMineolaNew York11501-
ImClone Investigational SiteNew YorkNew York10016-
ImClone Investigational SiteRexfordNew York12148-
ImClone Investigational SiteStony BrookNew York11794-
ImClone Investigational SiteThe BronxNew York10466-
ImClone Investigational SiteValhallaNew York10595-
ImClone Investigational SiteDurhamNorth Carolina27710-
ImClone Investigational SiteGreenvilleNorth Carolina27834-
ImClone Investigational SiteHigh PointNorth Carolina27262-
ImClone Investigational SiteRaleighNorth Carolina27609-
ImClone Investigational SiteWinston-SalemNorth Carolina27103-
ImClone Investigational SiteWinston-SalemNorth Carolina27157-
ImClone Investigational SiteBismarckNorth Dakota58501-
ImClone Investigational SiteCincinnatiOhio45267-
ImClone Investigational SiteClevelandOhio44106-
ImClone Investigational SiteColumbusOhio43235-
ImClone Investigational SiteDaytonOhio45459-
ImClone Investigational SiteNewarkOhio43055-
ImClone Investigational SiteOklahoma CityOklahoma73118-
ImClone Investigational SiteHersheyPennsylvania17033-
ImClone Investigational SitePhiladelphiaPennsylvania19106-
ImClone Investigational SitePhiladelphiaPennsylvania19107-
ImClone Investigational SitePhiladelphiaPennsylvania19141-3098-
ImClone Investigational SitePittsburghPennsylvania15232-
ImClone Investigational SiteGreenvilleSouth Carolina29615-
ImClone Investigational SiteKnoxvilleTennessee37916-
ImClone Investigational SiteMemphisTennessee38120-
ImClone Investigational SiteNashvilleTennessee37203-
ImClone Investigational SiteAustinTexas78759-
ImClone Investigational SiteDallasTexas75230-
ImClone Investigational SiteHoustonTexas77030-
ImClone Investigational SitePlanoTexas75075-
ImClone Investigational SiteTempleTexas76508-
ImClone Investigational SiteOgdenUtah84403-
ImClone Investigational SiteArlingtonVirginia22205-
ImClone Investigational SiteDanvilleVirginia24541-
ImClone Investigational SiteNewport NewsVirginia23606-
ImClone Investigational SiteRichmondVirginia23230-
ImClone Investigational SiteSeattleWashington98104-
ImClone Investigational SiteSpokaneWashington99204-
ImClone Investigational SiteSpokaneWashington99218-
ImClone Investigational SiteWalla WallaWashington99362-
ImClone Investigational SiteGreen BayWisconsin54301-
ImClone Investigational SiteMadisonWisconsin53792-
ImClone Investigational SiteMilwaukeeWisconsin53226-

Find similar trials in Tucson, AZ

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
ImClone Investigational Site· Tucson, AZImClone Investigational Site· Pine Bluff, ARImClone Investigational Site· Bakersfield, CAImClone Investigational Site· Berkeley, CAImClone Investigational Site· Beverly Hills, CAImClone Investigational Site· Corona, CA

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