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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 Carolina Charleston, South Carolina  29425-0721
University of Washington Medical Center Seattle, Washington  98195-6043
Hurley Medical Center Flint, Michigan  48503
Loyola University Medical Center Maywood, Illinois  60153
Sutter Health Western Division Cancer Research Group Greenbrae, California  94904
Loma Linda University Medical Center Loma Linda, California  92354
Boston Medical Center Boston, Massachusetts  02118
William Beaumont Hospital Royal Oak, Michigan  48073
Via Christi Regional Medical Center Wichita, Kansas  67214
Group Health Cooperative Seattle, Washington  98112
Great Falls Clinic Great Falls, Montana  59405
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
Kalispell Regional Medical Center Kalispell, Montana  59901
Adena Regional Medical Center Chillicothe, Ohio  54601
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Harborview Medical Center Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Welch Cancer Center Sheridan, Wyoming  82801
Poudre Valley Hospital Fort Collins, Colorado  80524
Grandview Hospital Dayton, Ohio  45405
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Northeast Georgia Medical Center Gainesville, Georgia  30501
Miami Valley Hospital Dayton, Ohio  45409
Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Menorah Medical Center Overland Park, Kansas  66209
Shawnee Mission Medical Center Shawnee Mission, Kansas  66204
North Kansas City Hospital Kansas City, Missouri  64116
Research Medical Center Kansas City, Missouri  64132
Saint Luke's East - Lee's Summit Lee's Summit, Missouri  64086
Liberty Hospital Liberty, Missouri  64068
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Mary Rutan Hospital Bellefontaine, Ohio  43311
Wayne Hospital Greenville, Ohio  45331
Knox Community Hospital Mount Vernon, Ohio  43050
Clinton Memorial Hospital Wilmington, Ohio  45177
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Rocky Mountain Oncology Casper, Wyoming  82609
Greene Memorial Hospital Xenia, Ohio  45385
Memorial Medical Center Springfield, Illinois  62781
Wellmont Holston Valley Hospital and Medical Center Kingsport, Tennessee  37662
Queen's Medical Center Honolulu, Hawaii  96813
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Maui Memorial Medical Center Wailuku, Hawaii  96793
University of Arizona Health Sciences Center Tucson, Arizona  85724
Straub Clinic and Hospital Honolulu, Hawaii  96813
Riverside Methodist Hospital Columbus, Ohio  43214
Licking Memorial Hospital Newark, Ohio  43055-2899
Columbus CCOP Columbus, Ohio  43206
Wichita CCOP Wichita, Kansas  67214-3882
Montana Cancer Consortium CCOP Billings, Montana  59101
UC Davis Comprehensive Cancer Center Sacramento, California  95817
Decatur Memorial Hospital Decatur, Illinois  62526
Montana Cancer Specialists Missoula, Montana  59807-7877
Memorial Health University Medical Center Savannah, Georgia  31404
University of Southern California Los Angeles, California  90033
Hawaii Medical Center East Honolulu, Hawaii  96817
Fremont - Rideout Cancer Center Marysville, California  95901
Valley Medical Oncology Consultants Pleasanton, California  94588
Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
M D Anderson Cancer Center- Orlando Orlando, Florida  32806
Oncare Hawaii Inc-POB II Honolulu, Hawaii  96813
Oncare Hawaii Inc-Kuakini Honolulu, Hawaii  96817
University of Hawaii Honolulu, Hawaii  96813
Saint Francis Hospital and Health Centers Beech Grove, Indiana  46107
Reid Hospital and Health Care Services Richmond, Indiana  47374
Cancer Center of Kansas - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Kingman Kingman, Kansas  67068
Cancer Center of Kansas - Parsons Parsons, Kansas  67357
Cancer Center of Kansas - Pratt Pratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary Mercy Hospital Livonia, Michigan  48154
Saint Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Saint Joseph Mercy Port Huron Port Huron, Michigan  48060
Saint Mary's of Michigan Saginaw, Michigan  48601
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Saint Luke's Hospital of Kansas City Kansas City, Missouri  64111
Saint Joseph Health Center Kansas City, Missouri  64114
Hematology-Oncology Centers of the Northern Rockies PC Billings, Montana  59101
Saint Vincent Healthcare Billings, Montana  59101
Billings Clinic Billings, Montana  59107-7000
Benefis Healthcare- Sletten Cancer Institute Great Falls, Montana  59405
Berdeaux, Donald MD (UIA Investigator) Great Falls, Montana  59405
Saint Peter's Community Hospital Helena, Montana  59601
Glacier Oncology PLLC Kalispell, Montana  59901
Community Medical Hospital Missoula, Montana  59801
Saint Patrick Hospital - Community Hospital Missoula, Montana  59802
Gaston Memorial Hospital Gastonia, North Carolina  28054
Margaret R Pardee Memorial Hospital Hendersonville, North Carolina  28791
Doctors Hospital Columbus, Ohio  43228
Grant Medical Center Columbus, Ohio  43215
Mount Carmel Health Center West Columbus, Ohio  43222
Good Samaritan Hospital - Dayton Dayton, Ohio  45406
Dayton CCOP Dayton, Ohio  45429
Samaritan North Health Center Dayton, Ohio  45415
Blanchard Valley Hospital Findlay, Ohio  45840
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio  45005-1066
Kettering Medical Center Kettering, Ohio  45429
Marietta Memorial Hospital Marietta, Ohio  45750
Upper Valley Medical Center Troy, Ohio  45373
Saint Ann's Hospital Westerville, Ohio  43081
Genesis HealthCare System Zanesville, Ohio  43701
AnMed Health Hospital Anderson, South Carolina  29621
Upstate Carolina CCOP Spartanburg, South Carolina  29303
Harrison Bremerton Hematology and Oncology Bremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLC Kennewick, Washington  99336
Minor and James Medical PLLC Seattle, Washington  98104
The Polyclinic Seattle, Washington  98122
Swedish Medical Center-First Hill Seattle, Washington  98122-4307
University of California Medical Center At Irvine-Orange Campus Orange, California  92868
Cancer Center of Kansas-Liberal Liberal, Kansas  67901
Skagit Valley Hospital Mt. Vernon, Washington  98273
Evergreen Hematology and Oncology PS Spokane, Washington  99218
Saint Luke's South Hospital Overland Park, Kansas  66213
Heartland Hematology and Oncology Associates Incorporated Kansas City, Missouri  64118
Southwest Oncology Group San Antonio, Texas  78245
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
PeaceHealth Saint Joseph Medical Center Bellingham, Washington  98225
Springfield Regional Medical Center Springfield, Ohio  45505
Harrison Poulsbo Hematology and Oncology Poulsbo, Washington  98370