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Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients With Advanced Gallbladder Carcinoma or Cholangiocarcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adenocarcinoma of the Extrahepatic Bile Duct, Adenocarcinoma of the Gallbladder, Adenocarcinoma With Squamous Metaplasia of the Gallbladder, Anaplastic Carcinoma of the Gallbladder, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer

Thank you

Trial Information

Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients With Advanced Gallbladder Carcinoma or Cholangiocarcinoma


OBJECTIVES:

I. To assess the progression-free survival in patients with unresectable or metastatic
gallbladder carcinoma or cholangiocarcinoma treated with the combination of sorafenib
(sorafenib tosylate) and erlotinib (erlotinib hydrochloride).

II. To assess the overall survival in patients with unresectable or metastatic gallbladder
carcinoma or cholangiocarcinoma treated with the combination of sorafenib and erlotinib.

IV. To assess the frequency and severity of toxicities. V. To collect specimens for banking
for future research.

OUTLINE: This is a multicenter study.

Patients receive sorafenib tosylate orally (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.

After completion of study therapy, patients are followed up every 6 months for 3 years.


Inclusion Criteria:



- Cytologically or pathologically confirmed gallbladder carcinoma or cholangiocarcinoma

- No ampullary carcinoma

- Locally advanced unresectable or distant metastatic disease

- Measurable disease

- Patients with biliary obstruction must have decompression of the biliary tree by ERCP
and stenting or percutaneous drainage

- No prior systemic treatment for metastatic or unresectable locally advanced disease

- No known brain metastases

- Zubrod performance status of 0-1

- Leukocyte count ≥ 3,000/mm^3

- ANC ≥ 1,000/mm^3

- Platelet count ≥100,000/mm^3

- Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

- For patient who had decompression of the biliary tree within the past 14 days,
stability of the bilirubin level needs to be confirmed with two measurements
within 5 to 7 days of each other

- Serum albumin ≥ 2.5 g/dL

- AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for liver metastases)

- Creatinine clearance ≥ 60 mL/min

- Not pregnant or nursing

- Fertile patients must agree to use effective contraception

- No active biliary sepsis

- No bleeding diathesis

- No uncontrolled or clinically significant cardiovascular disease, including any of
the following:

- Myocardial infarction within the past 6 months

- Uncontrolled angina within the past 6 months

- NYHA class II-IV congestive heart failure

- Grade 3 cardiac valve dysfunction

- Cardiac arrhythmia not controlled by medication

- History of stroke or transient ischemic attack within the past 6 months

- History ofarterial thrombotic event of any type in the past 6 months

- No uncontrolled hypertension, as evidenced by systolic BP ≥ 150 mm Hg or diastolic BP
≥ 100 mm Hg, within the past 28 days

- Must be able to swallow and tolerate oral medications

- No gastrointestinal tract disease or prior abdominal surgery that results in an
inability to absorb oral medication

- No other prior malignancy except adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, adequately treated stage I or II cancer from which
the patient is currently in complete remission, or any other cancer from which the
patient has been disease-free within the past 3 years

- No concurrent grapefruit or its juice

- At least 6 months since 1 adjuvant or neoadjuvant regimen of chemotherapy, hormonal
therapy, immunotherapy, radiotherapy (to < 25% of bone marrow only), or
chemoradiotherapy before documented recurrence or metastatic disease

- No prior treatment with any antiangiogenic agent or any EGFR inhibitors for any
reason

- Concurrent multiple anti-hypertensive medications allowed

- No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy,
immunotherapy, or any other therapy, including herbal or alternative medications for
treatment of cancer

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years

Safety Issue:

No

Principal Investigator

Anthony El-Khoueiry

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-02027

NCT ID:

NCT01093222

Start Date:

April 2010

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Extrahepatic Bile Duct
  • Adenocarcinoma of the Gallbladder
  • Adenocarcinoma With Squamous Metaplasia of the Gallbladder
  • Anaplastic Carcinoma of the Gallbladder
  • Cholangiocarcinoma of the Extrahepatic Bile Duct
  • Cholangiocarcinoma of the Gallbladder
  • Recurrent Extrahepatic Bile Duct Cancer
  • Recurrent Gallbladder Cancer
  • Unresectable Extrahepatic Bile Duct Cancer
  • Unresectable Gallbladder Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Metaplasia
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Cholangiocarcinoma

Name

Location

Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of Washington Medical CenterSeattle, Washington  98195-6043
Hurley Medical CenterFlint, Michigan  48503
Loyola University Medical CenterMaywood, Illinois  60153
Sutter Health Western Division Cancer Research GroupGreenbrae, California  94904
Loma Linda University Medical CenterLoma Linda, California  92354
Boston Medical CenterBoston, Massachusetts  02118
William Beaumont HospitalRoyal Oak, Michigan  48073
Via Christi Regional Medical CenterWichita, Kansas  67214
Group Health CooperativeSeattle, Washington  98112
Great Falls ClinicGreat Falls, Montana  59405
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Regional Medical CenterKalispell, Montana  59901
Adena Regional Medical CenterChillicothe, Ohio  54601
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Harborview Medical CenterSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Welch Cancer CenterSheridan, Wyoming  82801
Poudre Valley HospitalFort Collins, Colorado  80524
Grandview HospitalDayton, Ohio  45405
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Northeast Georgia Medical CenterGainesville, Georgia  30501
Miami Valley HospitalDayton, Ohio  45409
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Menorah Medical CenterOverland Park, Kansas  66209
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
North Kansas City HospitalKansas City, Missouri  64116
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Mary Rutan HospitalBellefontaine, Ohio  43311
Wayne HospitalGreenville, Ohio  45331
Knox Community HospitalMount Vernon, Ohio  43050
Clinton Memorial HospitalWilmington, Ohio  45177
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Greene Memorial HospitalXenia, Ohio  45385
Memorial Medical CenterSpringfield, Illinois  62781
Wellmont Holston Valley Hospital and Medical CenterKingsport, Tennessee  37662
Queen's Medical CenterHonolulu, Hawaii  96813
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Maui Memorial Medical CenterWailuku, Hawaii  96793
University of Arizona Health Sciences CenterTucson, Arizona  85724
Straub Clinic and HospitalHonolulu, Hawaii  96813
Riverside Methodist HospitalColumbus, Ohio  43214
Licking Memorial HospitalNewark, Ohio  43055-2899
Columbus CCOPColumbus, Ohio  43206
Wichita CCOPWichita, Kansas  67214-3882
Montana Cancer Consortium CCOPBillings, Montana  59101
UC Davis Comprehensive Cancer CenterSacramento, California  95817
Decatur Memorial HospitalDecatur, Illinois  62526
Montana Cancer SpecialistsMissoula, Montana  59807-7877
Memorial Health University Medical CenterSavannah, Georgia  31404
University of Southern CaliforniaLos Angeles, California  90033
Hawaii Medical Center EastHonolulu, Hawaii  96817
Fremont - Rideout Cancer CenterMarysville, California  95901
Valley Medical Oncology ConsultantsPleasanton, California  94588
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
M D Anderson Cancer Center- OrlandoOrlando, Florida  32806
Oncare Hawaii Inc-POB IIHonolulu, Hawaii  96813
Oncare Hawaii Inc-KuakiniHonolulu, Hawaii  96817
University of HawaiiHonolulu, Hawaii  96813
Saint Francis Hospital and Health CentersBeech Grove, Indiana  46107
Reid Hospital and Health Care ServicesRichmond, Indiana  47374
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Saint Luke's Hospital of Kansas CityKansas City, Missouri  64111
Saint Joseph Health CenterKansas City, Missouri  64114
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Billings ClinicBillings, Montana  59107-7000
Benefis Healthcare- Sletten Cancer InstituteGreat Falls, Montana  59405
Berdeaux, Donald MD (UIA Investigator)Great Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Community Medical HospitalMissoula, Montana  59801
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Gaston Memorial HospitalGastonia, North Carolina  28054
Margaret R Pardee Memorial HospitalHendersonville, North Carolina  28791
Doctors HospitalColumbus, Ohio  43228
Grant Medical CenterColumbus, Ohio  43215
Mount Carmel Health Center WestColumbus, Ohio  43222
Good Samaritan Hospital - DaytonDayton, Ohio  45406
Dayton CCOPDayton, Ohio  45429
Samaritan North Health CenterDayton, Ohio  45415
Blanchard Valley HospitalFindlay, Ohio  45840
Atrium Medical Center-Middletown Regional HospitalFranklin, Ohio  45005-1066
Kettering Medical CenterKettering, Ohio  45429
Marietta Memorial HospitalMarietta, Ohio  45750
Upper Valley Medical CenterTroy, Ohio  45373
Saint Ann's HospitalWesterville, Ohio  43081
Genesis HealthCare SystemZanesville, Ohio  43701
AnMed Health HospitalAnderson, South Carolina  29621
Upstate Carolina CCOPSpartanburg, South Carolina  29303
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Minor and James Medical PLLCSeattle, Washington  98104
The PolyclinicSeattle, Washington  98122
Swedish Medical Center-First HillSeattle, Washington  98122-4307
University of California Medical Center At Irvine-Orange CampusOrange, California  92868
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
Skagit Valley HospitalMt. Vernon, Washington  98273
Evergreen Hematology and Oncology PSSpokane, Washington  99218
Saint Luke's South HospitalOverland Park, Kansas  66213
Heartland Hematology and Oncology Associates IncorporatedKansas City, Missouri  64118
Southwest Oncology GroupSan Antonio, Texas  78245
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
PeaceHealth Saint Joseph Medical CenterBellingham, Washington  98225
Springfield Regional Medical CenterSpringfield, Ohio  45505
Harrison Poulsbo Hematology and OncologyPoulsbo, Washington  98370