Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma
Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients With Advanced Gallbladder Carcinoma or Cholangiocarcinoma
5 other identifiers
interventional
40
1 country
141
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2010
Typical duration for phase_2
141 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2010
CompletedFirst Posted
Study publicly available on registry
March 25, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedResults Posted
Study results publicly available
January 29, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedJune 30, 2015
March 1, 2015
2.4 years
March 24, 2010
November 1, 2013
June 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
From date of registration to date of first documentation of progression or symptomatic deterioration (as defined in protocol), or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Up to 3 years
Secondary Outcomes (3)
Overall Survival
Up to 3 years
Objective Response
Up to 3 years
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Up to 3 years
Study Arms (1)
Treatment (sorafenib tosylate and erlotinib hydrochloride)
EXPERIMENTALPatients 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.
Interventions
Given PO
Given PO
Eligibility Criteria
You may qualify if:
- 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)
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (141)
The University of Arizona Medical Center-University Campus
Tucson, Arizona, 85724, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
Sutter Cancer Research Consortium
Novato, California, 94945, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Valley Medical Oncology Consultants
Pleasanton, California, 94588, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
UF Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Memorial University Medical Center
Savannah, Georgia, 31404, United States
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, 96813, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, 96817, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Maui Memorial Medical Center
Wailuku, Hawaii, 96793, United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701, United States
Central Illinois CCOP
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Memorial Medical Center
Springfield, Illinois, 62781-0001, United States
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, 46107, United States
Reid Hospital and Health Care Services
Richmond, Indiana, 47374, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67901, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park, Kansas, 66213, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Kansas City CCOP
Prairie Village, Kansas, 66208, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Shawnee Mission Medical Center
Shawnee Mission, Kansas, 66204, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas - Main Office
Wichita, Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Wichita CCOP
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Michigan Cancer Research Consortium CCOP
Ann Arbor, Michigan, 48106, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, 48124, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, 48060, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Saint Joseph Health Center
Kansas City, Missouri, 64114, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, 64118, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086, United States
Liberty Hospital
Liberty, Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Montana Cancer Consortium CCOP
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Frontier Cancer Center and Blood Institute-Billings
Billings, Montana, 59102, United States
Billings Clinic Cancer Center
Billings, Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Hospital
Missoula, Montana, 59801, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Gaston Memorial Hospital
Gastonia, North Carolina, 28054, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104, United States
Mary Rutan Hospital
Bellefontaine, Ohio, 43311, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Columbus CCOP
Columbus, Ohio, 43215, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Health Center
Dayton, Ohio, 45415, United States
Dayton CCOP
Dayton, Ohio, 45420, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Springfield Regional Medical Center
Springfield, Ohio, 45505, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Clinton Memorial Hospital
Wilmington, Ohio, 45177, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Genesis HealthCare System
Zanesville, Ohio, 43701, United States
AnMed Health Hospital
Anderson, South Carolina, 29621, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, 37660, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, 98310, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Skagit Valley Hospital
Mount Vernon, Washington, 98274, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, 98370, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Minor and James Medical PLLC
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Group Health Cooperative-Seattle
Seattle, Washington, 98112, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307, United States
The Polyclinic
Seattle, Washington, 98122, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Evergreen Hematology and Oncology PS
Spokane, Washington, 99218, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The first stage of accrual was met with 40 registered patients. Insufficient number of patients were alive and free from progression at four months to warrant accruing to a second stage.
Results Point of Contact
- Title
- Study Statistician
- Organization
- SWOG
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony El-Khoueiry
SWOG Cancer Research Network
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2010
First Posted
March 25, 2010
Study Start
April 1, 2010
Primary Completion
September 1, 2012
Study Completion
September 1, 2014
Last Updated
June 30, 2015
Results First Posted
January 29, 2014
Record last verified: 2015-03