Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01093222
Phase
PHASE2
Status
Completed

Conditions

  • Extrahepatic Bile Duct Adenocarcinoma
  • Gallbladder Adenocarcinoma
  • Gallbladder Adenocarcinoma With Squamous Metaplasia
  • Hilar Cholangiocarcinoma
  • Recurrent Extrahepatic Bile Duct Carcinoma
  • Recurrent Gallbladder Carcinoma
  • Undifferentiated Gallbladder Carcinoma
  • Unresectable Extrahepatic Bile Duct Carcinoma
  • Unresectable Gallbladder Carcinoma

Eligibility Criteria

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

Interventions

Study Details

This phase II trial is studying how well giving sorafenib tosylate together with erlotinib hydrochloride works in treating patients with locally advanced, unresectable, or metastatic gallbladder cancer or cholangiocarcinoma. Sorafenib tosylate and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

Key Dates

First listed
Mar 25, 2010
Start date
Apr 30, 2010
Status verified
Mar 2015
Primary completion
Sep 30, 2012
Completion
Sep 30, 2014

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (sorafenib tosylate and erlotinib hydrochloride)
    Patients receive sorafenib tosylate PO twice daily and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival [ Time Frame: Up to 3 years ]

Locations (141)

FacilityCityStateZIPSite coordinators
The University of Arizona Medical Center-University CampusTucsonArizona85724-
Loma Linda University Medical CenterLoma LindaCalifornia92354-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Fremont - Rideout Cancer CenterMarysvilleCalifornia95901-
Sutter Cancer Research ConsortiumNovatoCalifornia94945-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
Valley Medical Oncology ConsultantsPleasantonCalifornia94588-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Poudre Valley HospitalFort CollinsColorado80524-
Saint Francis Hospital and Medical CenterHartfordConnecticut06105-
UF Cancer Center at Orlando HealthOrlandoFlorida32806-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
Memorial University Medical CenterSavannahGeorgia31404-
Pali Momi Medical Center‘AieaHawaii96701-
Kapiolani Medical Center for Women and ChildrenHonoluluHawaii96826-
Oncare Hawaii Inc-KuakiniHonoluluHawaii96817-
Oncare Hawaii Inc-POB IIHonoluluHawaii96813-
Queen's Medical CenterHonoluluHawaii96813-
Straub Clinic and HospitalHonoluluHawaii96813-
The Cancer Center of Hawaii-LilihaHonoluluHawaii96817-
University of Hawaii Cancer CenterHonoluluHawaii96813-
Maui Memorial Medical CenterWailukuHawaii96793-
Central Illinois CCOPDecaturIllinois62526-
Decatur Memorial HospitalDecaturIllinois62526-
Loyola University Medical CenterMaywoodIllinois60153-
Memorial Medical CenterSpringfieldIllinois62781-0001-
Saint Francis Hospital and Health CentersBeech GroveIndiana46107-
Reid Hospital and Health Care ServicesRichmondIndiana47374-
Cancer Center of Kansas - ChanuteChanuteKansas66720-
Cancer Center of Kansas - Dodge CityDodge CityKansas67801-
Cancer Center of Kansas - El DoradoEl DoradoKansas67042-
Cancer Center of Kansas - Fort ScottFort ScottKansas66701-
Cancer Center of Kansas-IndependenceIndependenceKansas67301-
Cancer Center of Kansas-KingmanKingmanKansas67068-
Lawrence Memorial HospitalLawrenceKansas66044-
Cancer Center of Kansas-LiberalLiberalKansas67901-
Cancer Center of Kansas - NewtonNewtonKansas67114-
Menorah Medical CenterOverland ParkKansas66209-
Saint Luke's South HospitalOverland ParkKansas66213-
Cancer Center of Kansas - ParsonsParsonsKansas67357-
Kansas City CCOPPrairie VillageKansas66208-
Cancer Center of Kansas - PrattPrattKansas67124-
Cancer Center of Kansas - SalinaSalinaKansas67401-
Shawnee Mission Medical CenterShawnee MissionKansas66204-
Cancer Center of Kansas - WellingtonWellingtonKansas67152-
Associates In Womens HealthWichitaKansas67208-
Cancer Center of Kansas - Main OfficeWichitaKansas67214-
Cancer Center of Kansas-Wichita Medical Arts TowerWichitaKansas67208-
Via Christi Regional Medical CenterWichitaKansas67214-
Wichita CCOPWichitaKansas67214-
Cancer Center of Kansas - WinfieldWinfieldKansas67156-
Boston Medical CenterBostonMassachusetts02118-
Michigan Cancer Research Consortium CCOPAnn ArborMichigan48106-
Saint Joseph Mercy HospitalAnn ArborMichigan48106-0995-
Oakwood Hospital and Medical CenterDearbornMichigan48124-
Saint John Hospital and Medical CenterDetroitMichigan48236-
Genesys Regional Medical Center-West Flint CampusFlintMichigan48532-
Hurley Medical CenterFlintMichigan48502-
Allegiance HealthJacksonMichigan49201-
Sparrow HospitalLansingMichigan48912-
Saint Mary Mercy HospitalLivoniaMichigan48154-
Saint Joseph Mercy OaklandPontiacMichigan48341-
Saint Joseph Mercy Port HuronPort HuronMichigan48060-
William Beaumont Hospital-Royal OakRoyal OakMichigan48073-
Saint Mary's of MichiganSaginawMichigan48601-
Saint John Macomb-Oakland HospitalWarrenMichigan48093-
Heartland Hematology and Oncology Associates IncorporatedKansas CityMissouri64118-
North Kansas City HospitalKansas CityMissouri64116-
Research Medical CenterKansas CityMissouri64132-
Saint Joseph Health CenterKansas CityMissouri64114-
Saint Luke's Hospital of Kansas CityKansas CityMissouri64111-
Saint Luke's East - Lee's SummitLee's SummitMissouri64086-
Liberty HospitalLibertyMissouri64068-
Heartland Regional Medical CenterSaint JosephMissouri64506-
Billings Clinic Cancer CenterBillingsMontana59107-
Frontier Cancer Center and Blood Institute-BillingsBillingsMontana59102-
Montana Cancer Consortium CCOPBillingsMontana59101-
Northern Rockies Radiation Oncology CenterBillingsMontana59101-
Saint Vincent HealthcareBillingsMontana59101-
Bozeman Deaconess Cancer CenterBozemanMontana59715-
Bozeman Deaconess HospitalBozemanMontana59715-
Benefis Healthcare- Sletten Cancer InstituteGreat FallsMontana59405-
Berdeaux, Donald MD (UIA Investigator)Great FallsMontana59405-
Great Falls ClinicGreat FallsMontana59405-
Saint Peter's Community HospitalHelenaMontana59601-
Glacier Oncology PLLCKalispellMontana59901-
Kalispell Regional Medical CenterKalispellMontana59901-
Community Medical HospitalMissoulaMontana59801-
Montana Cancer SpecialistsMissoulaMontana59802-
Saint Patrick Hospital - Community HospitalMissoulaMontana59802-
Gaston Memorial HospitalGastoniaNorth Carolina28054-
Margaret R Pardee Memorial HospitalHendersonvilleNorth Carolina28791-
Southeast Cancer Control ConsortiumWinston-SalemNorth Carolina27104-
Mary Rutan HospitalBellefontaineOhio43311-
Adena Regional Medical CenterChillicotheOhio45601-
Columbus CCOPColumbusOhio43215-
Doctors HospitalColumbusOhio43228-
Grant Medical CenterColumbusOhio43215-
Mount Carmel Health Center WestColumbusOhio43222-
Riverside Methodist HospitalColumbusOhio43214-
Dayton CCOPDaytonOhio45420-
Good Samaritan Hospital - DaytonDaytonOhio45406-
Grandview HospitalDaytonOhio45405-
Miami Valley HospitalDaytonOhio45409-
Samaritan North Health CenterDaytonOhio45415-
Grady Memorial HospitalDelawareOhio43015-
Blanchard Valley HospitalFindlayOhio45840-
Atrium Medical Center-Middletown Regional HospitalFranklinOhio45005-1066-
Wayne HospitalGreenvilleOhio45331-
Kettering Medical CenterKetteringOhio45429-
Fairfield Medical CenterLancasterOhio43130-
Marietta Memorial HospitalMariettaOhio45750-
Knox Community HospitalMount VernonOhio43050-
Licking Memorial HospitalNewarkOhio43055-
Springfield Regional Medical CenterSpringfieldOhio45505-
Upper Valley Medical CenterTroyOhio45373-
Saint Ann's HospitalWestervilleOhio43081-
Clinton Memorial HospitalWilmingtonOhio45177-
Greene Memorial HospitalXeniaOhio45385-
Genesis HealthCare SystemZanesvilleOhio43701-
AnMed Health HospitalAndersonSouth Carolina29621-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Spartanburg Medical CenterSpartanburgSouth Carolina29303-
Wellmont Holston Valley Hospital and Medical CenterKingsportTennessee37660-
PeaceHealth Saint Joseph Medical CenterBellinghamWashington98225-
Harrison HealthPartners Hematology and Oncology-BremertonBremertonWashington98310-
Kadlec Clinic Hematology and OncologyKennewickWashington99336-
Skagit Valley HospitalMount VernonWashington98274-
Harrison HealthPartners Hematology and Oncology-PoulsboPoulsboWashington98370-
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattleWashington98109-
Group Health Cooperative-SeattleSeattleWashington98112-
Harborview Medical CenterSeattleWashington98104-
Minor and James Medical PLLCSeattleWashington98104-
Swedish Medical Center-First HillSeattleWashington98122-4307-
The PolyclinicSeattleWashington98122-
University of Washington Medical CenterSeattleWashington98195-
Cancer Care Northwest - Spokane SouthSpokaneWashington99202-
Evergreen Hematology and Oncology PSSpokaneWashington99218-
Wenatchee Valley Hospital and ClinicsWenatcheeWashington98801-
Rocky Mountain OncologyCasperWyoming82609-
Welch Cancer CenterSheridanWyoming82801-

Find similar trials in Tucson, AZ

By research site
The University of Arizona Medical Center-University Campus· Tucson, AZLoma Linda University Medical Center· Loma Linda, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAFremont - Rideout Cancer Center· Marysville, CASutter Cancer Research Consortium· Novato, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CA

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