S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
About this trial
This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring cholangiocarcinoma of the extrahepatic bile duct, cholangiocarcinoma of the gallbladder, localized extrahepatic bile duct cancer, localized gallbladder cancer, unresectable extrahepatic bile duct cancer, unresectable gallbladder cancer, metastatic extrahepatic bile duct cancer, metastatic gallbladder cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histopathologically confirmed extrahepatic cholangiocarcinoma of the gallbladder or bile duct, meeting at least 1 of the following criteria:
- Pathological T2-4 disease
- Pathological N1 disease
- Positive margins (any T or N )
- Must have undergone potentially curative radical resection with negative (R0) or microscopically positive (R1) margins within the past 56 days and recovered (R0 stratum closed as of 12-15-11)
No distant metastatic disease as indicated by a CT scan or MRI of the chest, abdomen, and pelvis within the past 42 days
- Positive resected regional lymph nodes allowed
- No ampullary cancer
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- ANC > 1,500/μL
- Platelet count > 100,000/μL
- Serum creatinine < 1.5 mg/dL
- Total bilirubin < 1.5 times upper limit of normal (ULN)
- SGOT or SGPT < 2.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Able to swallow enteral medications and no requirement for a feeding tube
- No intractable nausea or vomiting
- No gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, requirement for IV alimentation, prior surgical procedures affecting absorptions. or uncontrolled inflammatory GI disease (e.g., Crohn disease, ulcerative colitis)
No uncontrolled intercurrent illness including but not limited to any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Myocardial infarction or cerebrovascular accident within the past 3 months
- Uncontrolled diarrhea
- Psychiatric illness or social situations that would limit compliance with study requirements
- No prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for 5 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy for this disease
- No prior upper abdominal radiotherapy
Sites / Locations
- Regional Medical Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Alta Bates Summit Comprehensive Cancer Center
- Peninsula Medical Center
- Rebecca and John Moores UCSD Cancer Center
- Kaiser Permanente Medical Center - Los Angeles
- USC/Norris Comprehensive Cancer Center and Hospital
- Sutter Health - Western Division Cancer Research Group
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- California Pacific Medical Center - California Campus
- Sutter Pacific Medical Foundation
- Sutter Solano Medical Center
- Aurora Presbyterian Hospital
- University of Colorado Cancer Center at UC Health Sciences Center
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- St. Anthony Central Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program
- Shaw Regional Cancer Center
- Swedish Medical Center
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
- North Colorado Medical Center
- Littleton Adventist Hospital
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- McKee Medical Center
- Parker Adventist Hospital
- St. Mary - Corwin Regional Medical Center
- Exempla Lutheran Medical Center
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- Washington Cancer Institute at Washington Hospital Center
- Piedmont Hospital
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- CCOP - Atlanta Regional
- WellStar Cobb Hospital
- John B. Amos Cancer Center
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Piedmont Fayette Hospital
- Gwinnett Medical Center
- Medical Center of Central Georgia
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Cancer Center - Medical Oncology
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Hematology and Oncology Associates
- University of Chicago Cancer Research Center
- Decatur Memorial Hospital Cancer Care Institute
- Kellogg Cancer Care Center
- Provena St. Mary's Regional Cancer Center - Kankakee
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Edward Hospital Cancer Center
- Cancer Care and Hematology Specialists of Chicagoland - Niles
- Hematology Oncology Associates - Skokie
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Reid Hospital & Health Care Services
- Medical Oncology and Hematology Associates - West Des Moines
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas - Fort Scott
- St. Rose Ambulatory and Surgery Center
- Hays Medical Center
- Hutchinson Hospital Corporation
- Cancer Center of Kansas-Independence
- Kansas City Cancer Centers - West
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas, PA - Liberal
- Cancer Center of Kansas, PA - McPherson
- Cancer Center of Kansas, PA - Newton
- Kansas City Cancer Centers - Southwest
- Cancer Center of Kansas, PA - Parsons
- Mount Carmel Regional Cancer Center
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Tammy Walker Cancer Center at Salina Regional Health Center
- Kansas City Cancer Center - Shawnee Mission
- St. Francis Comprehensive Cancer Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- CCOP - Ochsner
- Ochsner Cancer Institute at Ochsner Clinic Foundation
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Union Hospital of Cecil County
- Boston University Cancer Research Center
- Lahey Clinic Medical Center - Burlington
- Hickman Cancer Center at Bixby Medical Center
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Mercy Memorial Hospital - Monroe
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- New Ulm Medical Center
- Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Willmar Cancer Center at Rice Memorial Hospital
- Minnesota Oncology - Woodbury
- University of Mississippi Cancer Clinic
- Truman Medical Center - Hospital Hill
- Kansas City Cancer Centers - South
- Kansas City Cancer Centers - North
- Kansas City Cancer Centers - East
- CCOP - Montana Cancer Consortium
- St. Vincent Healthcare Cancer Care Services
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Memorial Sloan-Kettering Cancer Center - Basking Ridge
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- Cancer Institute of New Jersey at Cooper - Voorhees
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Memorial Sloan-Kettering Cancer Center
- CCOP - Hematology-Oncology Associates of Central New York
- Tucker Center for Cancer Care at Orange Regional Medical Center
- Memorial Sloan-Kettering Cancer Center - Rockville Centre
- Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
- SUNY Upstate Medical University Hospital
- Blumenthal Cancer Center at Carolinas Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Wayne Memorial Hospital, Incorporated
- Rutherford Hospital
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- Summa Center for Cancer Care at Akron City Hospital
- Barberton Citizens Hospital
- Charles M. Barrett Cancer Center at University Hospital
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Community Cancer Center
- Hematology Oncology Center
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Charles F. Kettering Memorial Hospital
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- St. Charles Mercy Hospital
- North Coast Cancer Care, Incorporated
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- St. Anne Mercy Hospital
- Toledo Clinic, Incorporated - Main Clinic
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Clackamas Radiation Oncology Center
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Willamette Falls Hospital
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Fox Chase Cancer Center - Philadelphia
- UPMC Cancer Centers
- AnMed Cancer Center
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- M. D. Anderson Cancer Center at University of Texas
- American Fork Hospital
- Sandra L. Maxwell Cancer Center
- Logan Regional Hospital
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Utah Cancer Specialists at UCS Cancer Center
- LDS Hospital
- Danville Regional Medical Center
- Fredericksburg Oncology, Incorporated
- Lynchburg Hematology-Oncology Clinic
- Island Hospital Cancer Care Center at Island Hospital
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Highline Medical Center Cancer Center
- Swedish Medical Center - Issaquah Campus
- Columbia Basin Hematology
- Skagit Valley Hospital Cancer Care Center
- Harrison Poulsbo Hematology and Onocology
- Harborview Medical Center
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Evergreen Hematology and Oncology, PS
- Southwest Washington Medical Center Cancer Center
- Northwest Cancer Specialists at Vancouver Cancer Center
- Wenatchee Valley Medical Center
- Medical College of Wisconsin Cancer Center
- Rocky Mountain Oncology
Arms of the Study
Arm 1
Experimental
Adjuvant Chemo+ Chemoradiotherapy
Adjuvant Chemotherapy Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle Chemoradiotherapy -Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions. intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.