S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
About this trial
This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring unresectable gallbladder cancer, recurrent gallbladder cancer, unresectable extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, adenocarcinoma of the gallbladder, adenocarcinoma with squamous metaplasia of the gallbladder, squamous cell carcinoma of the gallbladder, adenocarcinoma of the extrahepatic bile duct, cholangiocarcinoma of the gallbladder, cholangiocarcinoma of the extrahepatic bile duct
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed gallbladder cancer or cholangiocarcinoma Locally advanced or metastatic disease that is unresectable Eligible subtypes: Adenocarcinoma, intestinal type Adenocarcinoma, not otherwise specified (NOS) Papillary carcinoma Clear cell adenocarcinoma Mucinous carcinoma Signet ring cell carcinoma Squamous cell carcinoma Adenosquamous carcinoma Small cell carcinoma Undifferentiated carcinoma Carcinoma, NOS OR Histologically confirmed adenocarcinoma of a metastatic site with clinical documentation* of gallbladder or bile duct involvement and no evidence of another primary NOTE: *If clinical documentation of gallbladder or bile duct involvement is not possible due to removal of the organ, a clinically and/or radiographically consistent picture plus pathologic findings from the metastatic site consistent with cholangiocarcinoma are allowed Measurable disease located outside prior radiotherapy port No carcinoid tumors or sarcomas PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) no greater than 2.5 times ULN (5 times ULN if liver metastasis is present) Renal: Creatinine clearance at least 30 mL/min Cardiovascular: No clinically significant cardiac disease that is not well controlled by medication No congestive heart failure No symptomatic coronary artery disease No cardiac arrhythmias No myocardial infarction within the past 12 months Gastrointestinal: Able to swallow and/or receive medications via gastrostomy feeding tube No intractable nausea or vomiting No malabsorption syndrome Other: No severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil No other malignancy within the past 5 years except: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Adequately treated stage I or II cancer currently in complete remission Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Prior neoadjuvant or adjuvant immunotherapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease No concurrent immunotherapy Chemotherapy: Prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease No other concurrent chemotherapy Endocrine therapy: Prior neoadjuvant or adjuvant hormonal therapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease No concurrent hormonal therapy Radiotherapy: See Disease Characteristics See Chemotherapy Recovered from prior radiotherapy Prior neoadjuvant or adjuvant radiotherapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease No prior radiotherapy to 25% or more of bone marrow No concurrent radiotherapy except for palliation of metastatic sites not considered target lesions Surgery: At least 2 weeks since prior surgery for this malignancy and recovered Other: No prior treatment for metastatic disease No other concurrent therapy for this cancer
Sites / Locations
- Mobile Infirmary Medical Center
- Providence Alaska Medical Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Alta Bates Comprehensive Cancer Center
- North Bay Cancer Center
- Marin Cancer Institute at Marin General Hospital
- Sutter Health Western Division Cancer Research Group
- USC/Norris Comprehensive Cancer Center and Hospital
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Memorial Hospital Cancer Center
- West Florida Regional Medical Center
- Hematology Oncology Associates of Eastern Idaho
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Cancer Care Center at St. Francis Hospital
- South Central Kansas Regional Medical Center
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Cancer Center of Kansas - Kingman
- Southwest Medical Center
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Pratt Cancer Center of Kansas
- Salina Regional Health Center
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates in Womens Health
- Cancer Center of Kansas, P.A. - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas - Winfield
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- Louisiana State University Health Sciences Center - Monroe
- Tulane Cancer Center at Tulane University Hospital and Clinic
- Cancer Treatment Center at Christus Schumpert St. Mary Place
- Veterans Affairs Medical Center - Shreveport
- Louisiana State University Health Sciences Center - Shreveport
- Cancer Center at Thibodaux Regional Medical Center
- Battle Creek Health System
- Mecosta County General Hospital
- Josephine Ford Cancer Center at Henry Ford Health System
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Mercy Medical Center
- Spectrum Health Cancer Care - Butterworth Campus
- Metropolitan Hospital
- Spectrum Health Hospital - Blodgett Campus
- Holland Community Hospital
- Hackley Hospital
- Northern Michigan Hospital
- Munson Medical Center
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
- St. Francis Medical Center
- CCOP - Kansas City
- CCOP - St. Louis-Cape Girardeau
- Center for Cancer Care and Research
- David C. Pratt Cancer Center at St. John's Mercy
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Great Falls Clinic
- Sletten Regional Cancer Institute
- Veterans Affairs Medical Center - Albuquerque
- Adirondack Cancer Care
- Orange Regional Medical Center - Horton Campus
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Mission Hospitals - Memorial Campus
- Blumenthal Cancer Center at Carolinas Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Wayne Memorial Hospital, Incorporated
- Cancer Center at Iredell Memorial Hospital
- Forsyth Regional Cancer Center at Forsyth Medical Center
- University Hospitals Ireland Cancer Center at Mercy Medical Center
- Adena Regional Medical Center
- Veterans Affairs Medical Center - Cincinnati
- Charles M. Barrett Cancer Center at University Hospital
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Riverside Methodist Hospital Cancer Care
- Grandview Hospital
- Good Samaritan Hospital
- Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Grady Memorial Hospital
- Community Oncology Group - Independence
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- Strecker Cancer Center at Marietta Memorial Hospital
- Middletown Regional Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Community Hospital of Springfield and Clark County
- UVMC Cancer Care Center at Upper Valley Medical Center
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Cancer Institute at Oregon Health and Science University
- Hollings Cancer Center at Medical University of South Carolina
- McLeod Regional Medical Center
- Bon Secours St. Francis Health System
- CCOP - Greenville
- Veterans Affairs Medical Center - Amarillo
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute at University of Utah
- Memorial Hospital of Martinsville and Henry County
- St. Joseph Hospital Community Cancer Center
- Harborview Medical Center
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Veterans Affairs Medical Center - Seattle
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- University Cancer Center at University of Washington Medical Center
- Central Washington Hospital
- Wenatchee Valley Clinic
Arms of the Study
Arm 1
Experimental
Capecitabine + Gemcitabine
Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days