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Spots Global Cancer Trial Database for Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma

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Trial Identification

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

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

Study ID: NCT01093222

Study Description

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.

Detailed Description: 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. III. To assess the objective response rate. 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

The University of Arizona Medical Center-University Campus, Tucson, Arizona, United States

Loma Linda University Medical Center, Loma Linda, California, United States

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

Fremont - Rideout Cancer Center, Marysville, California, United States

Sutter Cancer Research Consortium, Novato, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States

Valley Medical Oncology Consultants, Pleasanton, California, United States

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Poudre Valley Hospital, Fort Collins, Colorado, United States

Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States

UF Cancer Center at Orlando Health, Orlando, Florida, United States

Northeast Georgia Medical Center, Gainesville, Georgia, United States

Memorial University Medical Center, Savannah, Georgia, United States

Pali Momi Medical Center, Aiea, Hawaii, United States

Oncare Hawaii Inc-POB II, Honolulu, Hawaii, United States

Queen's Medical Center, Honolulu, Hawaii, United States

Straub Clinic and Hospital, Honolulu, Hawaii, United States

University of Hawaii Cancer Center, Honolulu, Hawaii, United States

Oncare Hawaii Inc-Kuakini, Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States

Maui Memorial Medical Center, Wailuku, Hawaii, United States

Central Illinois CCOP, Decatur, Illinois, United States

Decatur Memorial Hospital, Decatur, Illinois, United States

Loyola University Medical Center, Maywood, Illinois, United States

Memorial Medical Center, Springfield, Illinois, United States

Saint Francis Hospital and Health Centers, Beech Grove, Indiana, United States

Reid Hospital and Health Care Services, Richmond, Indiana, United States

Cancer Center of Kansas - Chanute, Chanute, Kansas, United States

Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States

Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States

Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States

Cancer Center of Kansas-Independence, Independence, Kansas, United States

Cancer Center of Kansas-Kingman, Kingman, Kansas, United States

Lawrence Memorial Hospital, Lawrence, Kansas, United States

Cancer Center of Kansas-Liberal, Liberal, Kansas, United States

Cancer Center of Kansas - Newton, Newton, Kansas, United States

Menorah Medical Center, Overland Park, Kansas, United States

Saint Luke's South Hospital, Overland Park, Kansas, United States

Cancer Center of Kansas - Parsons, Parsons, Kansas, United States

Kansas City CCOP, Prairie Village, Kansas, United States

Cancer Center of Kansas - Pratt, Pratt, Kansas, United States

Cancer Center of Kansas - Salina, Salina, Kansas, United States

Shawnee Mission Medical Center, Shawnee Mission, Kansas, United States

Cancer Center of Kansas - Wellington, Wellington, Kansas, United States

Associates In Womens Health, Wichita, Kansas, United States

Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States

Cancer Center of Kansas - Main Office, Wichita, Kansas, United States

Via Christi Regional Medical Center, Wichita, Kansas, United States

Wichita CCOP, Wichita, Kansas, United States

Cancer Center of Kansas - Winfield, Winfield, Kansas, United States

Boston Medical Center, Boston, Massachusetts, United States

Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States

Michigan Cancer Research Consortium CCOP, Ann Arbor, Michigan, United States

Oakwood Hospital and Medical Center, Dearborn, Michigan, United States

Saint John Hospital and Medical Center, Detroit, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Genesys Regional Medical Center-West Flint Campus, Flint, Michigan, United States

Allegiance Health, Jackson, Michigan, United States

Sparrow Hospital, Lansing, Michigan, United States

Saint Mary Mercy Hospital, Livonia, Michigan, United States

Saint Joseph Mercy Oakland, Pontiac, Michigan, United States

Saint Joseph Mercy Port Huron, Port Huron, Michigan, United States

William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, United States

Saint Mary's of Michigan, Saginaw, Michigan, United States

Saint John Macomb-Oakland Hospital, Warren, Michigan, United States

Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States

Saint Joseph Health Center, Kansas City, Missouri, United States

North Kansas City Hospital, Kansas City, Missouri, United States

Heartland Hematology and Oncology Associates Incorporated, Kansas City, Missouri, United States

Research Medical Center, Kansas City, Missouri, United States

Saint Luke's East - Lee's Summit, Lee's Summit, Missouri, United States

Liberty Hospital, Liberty, Missouri, United States

Heartland Regional Medical Center, Saint Joseph, Missouri, United States

Montana Cancer Consortium CCOP, Billings, Montana, United States

Northern Rockies Radiation Oncology Center, Billings, Montana, United States

Saint Vincent Healthcare, Billings, Montana, United States

Frontier Cancer Center and Blood Institute-Billings, Billings, Montana, United States

Billings Clinic Cancer Center, Billings, Montana, United States

Bozeman Deaconess Cancer Center, Bozeman, Montana, United States

Bozeman Deaconess Hospital, Bozeman, Montana, United States

Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States

Berdeaux, Donald MD (UIA Investigator), Great Falls, Montana, United States

Great Falls Clinic, Great Falls, Montana, United States

Saint Peter's Community Hospital, Helena, Montana, United States

Glacier Oncology PLLC, Kalispell, Montana, United States

Kalispell Regional Medical Center, Kalispell, Montana, United States

Community Medical Hospital, Missoula, Montana, United States

Montana Cancer Specialists, Missoula, Montana, United States

Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States

Gaston Memorial Hospital, Gastonia, North Carolina, United States

Margaret R Pardee Memorial Hospital, Hendersonville, North Carolina, United States

Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States

Mary Rutan Hospital, Bellefontaine, Ohio, United States

Adena Regional Medical Center, Chillicothe, Ohio, United States

Riverside Methodist Hospital, Columbus, Ohio, United States

Columbus CCOP, Columbus, Ohio, United States

Grant Medical Center, Columbus, Ohio, United States

Mount Carmel Health Center West, Columbus, Ohio, United States

Doctors Hospital, Columbus, Ohio, United States

Grandview Hospital, Dayton, Ohio, United States

Good Samaritan Hospital - Dayton, Dayton, Ohio, United States

Miami Valley Hospital, Dayton, Ohio, United States

Samaritan North Health Center, Dayton, Ohio, United States

Dayton CCOP, Dayton, Ohio, United States

Grady Memorial Hospital, Delaware, Ohio, United States

Blanchard Valley Hospital, Findlay, Ohio, United States

Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States

Wayne Hospital, Greenville, Ohio, United States

Kettering Medical Center, Kettering, Ohio, United States

Fairfield Medical Center, Lancaster, Ohio, United States

Marietta Memorial Hospital, Marietta, Ohio, United States

Knox Community Hospital, Mount Vernon, Ohio, United States

Licking Memorial Hospital, Newark, Ohio, United States

Springfield Regional Medical Center, Springfield, Ohio, United States

Upper Valley Medical Center, Troy, Ohio, United States

Saint Ann's Hospital, Westerville, Ohio, United States

Clinton Memorial Hospital, Wilmington, Ohio, United States

Greene Memorial Hospital, Xenia, Ohio, United States

Genesis HealthCare System, Zanesville, Ohio, United States

AnMed Health Hospital, Anderson, South Carolina, United States

Medical University of South Carolina, Charleston, South Carolina, United States

Spartanburg Medical Center, Spartanburg, South Carolina, United States

Wellmont Holston Valley Hospital and Medical Center, Kingsport, Tennessee, United States

PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States

Harrison HealthPartners Hematology and Oncology-Bremerton, Bremerton, Washington, United States

Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States

Skagit Valley Hospital, Mount Vernon, Washington, United States

Harrison HealthPartners Hematology and Oncology-Poulsbo, Poulsbo, Washington, United States

Harborview Medical Center, Seattle, Washington, United States

Minor and James Medical PLLC, Seattle, Washington, United States

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Group Health Cooperative-Seattle, Seattle, Washington, United States

Swedish Medical Center-First Hill, Seattle, Washington, United States

The Polyclinic, Seattle, Washington, United States

University of Washington Medical Center, Seattle, Washington, United States

Cancer Care Northwest - Spokane South, Spokane, Washington, United States

Evergreen Hematology and Oncology PS, Spokane, Washington, United States

Wenatchee Valley Hospital and Clinics, Wenatchee, Washington, United States

Rocky Mountain Oncology, Casper, Wyoming, United States

Welch Cancer Center, Sheridan, Wyoming, United States

Contact Details

Name: Anthony El-Khoueiry

Affiliation: SWOG Cancer Research Network

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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