PhII ICb With/Without Erbitux in MBC Pts

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
US Oncology Research
Study ID
NCT00248287
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to determine the objective response rates produced by irinotecan and carboplatin therapy with or without Erbitux in patients with Metastatic Breast Cancer.

Key Dates

Start date
Jul 28, 2005
Status verified
Jan 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
154 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1
    irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle (Arm 1, ICb)
  • Experimental: Arm 2
    irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2 Week 1 and then 250 mg/m2 weekly thereafter, (Arm 2, ICb+Erbitux)

Primary Outcome Measure

Objective Response Rates (ORR) [ Time Frame: 2 years ]

Locations (59)

FacilityCityStateZIPSite coordinators
Birmingham Hematology and OncologyBirminghamAlabama35205-
Hematology Oncology AsscociatesPhoenixArizona85012-
Northern AZ Hematology & Oncology AssocSedonaArizona86336-
Rocky Mountain Cancer Center-RoseDenverColorado80220-
Northwestern Connecticut Oncology Hematology AssociatesTorringtonConnecticut06790-
Melbourne Internal Medicine AssociatesMelbourneFlorida32901-
Florida Cancer InstituteNew Port RicheyFlorida34655-
Ocala Oncology CenterOcalaFlorida34474-
Cancer Centers of Florida, P.A.OcoeeFlorida34761-
Hematology Oncology Associates of ILChicagoIllinois60611-
Central Indiana Cancer CenterIndianapolisIndiana46227-
Kansas City Cancer-SouthwestOverland ParkKansas66210-
Maryland Oncology Hematology, P.A.ColumbiaMaryland21044-
Minnesota Oncology Hematology, P.A.MinneapolisMinnesota55404-
Missouri Cancer AssociatesColumbiaMissouri65201-
Arch Medical Services, IncSt LouisMissouri63141-
Comprehensive Cancer Centers of NevadaLas VegasNevada89109-
NH Oncology-Hematology PAHooksettNew Hampshire03106-
Hematology-Oncology Associates of NNJ, P.A.MorristownNew Jersey07960-
Summit Medical GroupSummitNew Jersey07901-
New York Oncology Hematology, P.C.AlbanyNew York12208-
New York Oncology Hematology, PCRexfordNew York12148-
Interlakes Oncology Hematology, PCRochesterNew York14623-
Raleigh Hematology Oncology ClinicCaryNorth Carolina27511-
Greater Dayton Cancer CenterKetteringOhio45409-
Willamette Valley Cancer CenterEugeneOregon97401-
Cancer Center of the Carolinas, SenecaSenecaSouth Carolina29672-
Texas Cancer Center-Abilene(South)AbileneTexas79606-
Texas Cancer CenterArlingtonTexas76014-
Texas Oncology Cancer CenterAustinTexas78731-
Mamie McFaddin Ward Cancer CenterBeaumontTexas77702-
Texas Oncology, P.A. - BedfordBedfordTexas76022-
Texas Cancer Center at Medical CityDallasTexas75230-
Texas Oncology, P.A.DallasTexas75231-
Texas Oncology, P.A.DallasTexas75246-
The Texas Cancer CenterDallasTexas75237-
Texas Oncology Center - DentonDentonTexas76210-
El Paso Cancer Treatment CtrEl PasoTexas79915-
Texas Oncology, P.A.Fort WorthTexas76104-
San Antonio Tumor & Blood ClinicFredericksburgTexas78624-
Texas Oncology, P.A.HoustonTexas77024-
Longview Cancer CenterLongviewTexas75601-
South Texas Cancer Center-McAllenMcAllenTexas78503-
Texas Cancer Center of MesquiteMesquiteTexas75150-
Allison Cancer CenterMidlandTexas79701-
HOAST - New BraunfelsNew BraunfelsTexas78131-
West Texas Cancer CenterOdessaTexas79761-
Paris Regional Cancer CenterParisTexas75460-
Texas Cancer Center-ShermanShermanTexas75090-
Texas Oncology Cancer Center-Sugar LandSugar LandTexas77479-
Tyler Cancer CenterTylerTexas75702-
Waco Cancer Care and Research CenterWacoTexas76712-
Virginia Oncology AssociatesNorfolkVirginia23505-
Onc and Hem Associates of SW VA, Inc.SalemVirginia24153-
Puget Sound Cancer Center-EmondsEdmondsWashington98026-
Puget Sound Cancer Center-SeattleSeattleWashington98133-
Cancer Care Northwest-SouthSpokaneWashington99202-
Northwest Cancer Specialists-VancouverVancouverWashington98684-
Yakima Valley Mem Hosp/North Star LodgeYakimaWashington98902-

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Birmingham Hematology and Oncology· Birmingham, ALHematology Oncology Asscociates· Phoenix, AZNorthern AZ Hematology & Oncology Assoc· Sedona, AZRocky Mountain Cancer Center-Rose· Denver, CONorthwestern Connecticut Oncology Hematology Associates· Torrington, CTMelbourne Internal Medicine Associates· Melbourne, FL

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