RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have locally advanced or metastatic gallbladder cancer or cholangiocarcinoma.

Condition	Treatment or Intervention	Phase
extrahepatic bile duct cancer Gallbladder Cancer	Drug: capecitabine  Drug: gemcitabine  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the response rates (confirmed complete and partial responses) in patients with unresectable, locally advanced or metastatic gallbladder cancer or cholangiocarcinoma treated with gemcitabine and capecitabine.
• Determine the overall survival of patients treated with this regimen.
• Determine the quantitative and qualitative toxic effects of this regimen in these patients.
• Determine the feasibility of accruing patients with these disease sites.
• Evaluate, preliminarily, relevant prognostic markers in these disease sites and the prognostic implications as predictors of survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 1-14 and gemcitabine IV over 100 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within approximately 10-20 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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)
• SGOT or 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

Alabama
      Mobile Infirmary Medical Center, Mobile,  Alabama,  36652-2144,  United States; Recruiting
Alaska
      Providence Alaska Medical Center, Anchorage,  Alaska,  99519-6604,  United States; Recruiting
Arkansas
      Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States; Recruiting
California
      Alta Bates Comprehensive Cancer Center, Berkeley,  California,  94704,  United States; Recruiting
      Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange,  California,  92868,  United States; Recruiting
      Marin Cancer Institute at Marin General Hospital, Greenbrae,  California,  94904,  United States; Recruiting
      North Bay Cancer Center, Fairfield,  California,  94533,  United States; Recruiting
      Sutter Health Western Division Cancer Research Group, Greenbrae,  California,  94904,  United States; Recruiting
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033,  United States; Recruiting
Colorado
      Memorial Hospital Cancer Center, Colorado Springs,  Colorado,  80909,  United States; Recruiting
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora,  Colorado,  80010,  United States; Recruiting
Florida
      West Florida Regional Medical Center, Pensacola,  Florida,  32514-6088,  United States; Recruiting
Idaho
      Hematology Oncology Associates of Eastern Idaho, Idaho Falls,  Idaho,  83404,  United States; Recruiting
Illinois
      Saint Anthony's Hospital at Saint Anthony's Health Center, Alton,  Illinois,  62002,  United States; Recruiting
Indiana
      Cancer Care Center at St. Francis Hospital, Indianapolis,  Indiana,  46237,  United States; Recruiting
Kansas
      Associates in Womens Health, Wichita,  Kansas,  67203,  United States; Recruiting
      Cancer Center of Kansas - Chanute, Chanute,  Kansas,  66720,  United States; Recruiting
      Cancer Center of Kansas - Dodge City, Dodge City,  Kansas,  67801,  United States; Recruiting
      Cancer Center of Kansas - Kingman, Kingman,  Kansas,  67068,  United States; Recruiting
      Cancer Center of Kansas - McPherson, McPherson,  Kansas,  67460,  United States; Recruiting
      Cancer Center of Kansas - Newton, Newton,  Kansas,  67114,  United States; Recruiting
      Cancer Center of Kansas - Salina, Salina,  Kansas,  67402,  United States; Recruiting
      Cancer Center of Kansas - Wellington, Wellington,  Kansas,  67152,  United States; Recruiting
      Cancer Center of Kansas - Winfield, Winfield,  Kansas,  67156,  United States; Recruiting
      Cancer Center of Kansas, P.A. - Wichita, Wichita,  Kansas,  67214-3728,  United States; Recruiting
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
      Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City,  Kansas,  66160-7353,  United States; Recruiting
      Pratt Cancer Center of Kansas, Pratt,  Kansas,  67124,  United States; Recruiting
      Salina Regional Health Center, Salina,  Kansas,  67401,  United States; Recruiting
      South Central Kansas Regional Medical Center, Arkansas City,  Kansas,  67005,  United States; Recruiting
      Southwest Medical Center, Liberal,  Kansas,  67901,  United States; Recruiting
      Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita,  Kansas,  67214,  United States; Recruiting
Kentucky
      Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536-0084,  United States; Recruiting
Louisiana
      Cancer Center at Thibodaux Regional Medical Center, Thibodaux,  Louisiana,  70302-1118,  United States; Recruiting
      Cancer Treatment Center at Christus Schumpert St. Mary Place, Shreveport,  Louisiana,  71101-0000,  United States; Recruiting
      Louisiana State University Health Sciences Center - Monroe, Monroe,  Louisiana,  71210,  United States; Recruiting
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States; Recruiting
      Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans,  Louisiana,  70112,  United States; Recruiting
      Veterans Affairs Medical Center - Shreveport, Shreveport,  Louisiana,  71101-4295,  United States; Recruiting
Michigan
      Battle Creek Health System, Battle Creek,  Michigan,  49016,  United States; Recruiting
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      Hackley Hospital, Muskegon,  Michigan,  49443-3302,  United States; Recruiting
      Holland Community Hospital, Holland,  Michigan,  49423,  United States; Recruiting
      Josephine Ford Cancer Center at Henry Ford Health System, Detroit,  Michigan,  48202,  United States; Recruiting
      Lacks Cancer Center at Saint Mary's Mercy Medical Center, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      Mecosta County General Hospital, Big Rapids,  Michigan,  49307,  United States; Recruiting
      Metropolitan Hospital, Grand Rapids,  Michigan,  49506,  United States; Recruiting
      Munson Medical Center, Traverse City,  Michigan,  49684,  United States; Recruiting
      Northern Michigan Hospital, Petoskey,  Michigan,  49770,  United States; Recruiting
      Spectrum Health Cancer Care - Butterworth Campus, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      Spectrum Health Hospital - Blodgett Campus, Grand Rapids,  Michigan,  49506,  United States; Recruiting
Missouri
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States; Recruiting
      Center for Cancer Care and Research, Saint Louis,  Missouri,  63141,  United States; Recruiting
      David C. Pratt Cancer Center at St. John's Mercy, Saint Louis,  Missouri,  63141,  United States; Recruiting
      Hulston Cancer Center at Cox Medical Center South, Springfield,  Missouri,  65807,  United States; Recruiting
      Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital, Cape Girardeau,  Missouri,  63701,  United States; Recruiting
      St. Francis Medical Center, Cape Girardeau,  Missouri,  63701,  United States; Recruiting
      St. John's Regional Health Center, Springfield,  Missouri,  65804-2263,  United States; Recruiting
Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States; Recruiting
      Great Falls Clinic, Great Falls,  Montana,  59403,  United States; Recruiting
      Sletten Regional Cancer Institute, Great Falls,  Montana,  59405,  United States; Recruiting
New Mexico
      Veterans Affairs Medical Center - Albuquerque, Albuquerque,  New Mexico,  87108-5138,  United States; Recruiting
New York
      Adirondack Cancer Care, Glens Falls,  New York,  12801,  United States; Recruiting
      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
      Orange Regional Medical Center - Horton Campus, Middletown,  New York,  10940-4199,  United States; Recruiting
North Carolina
      Blumenthal Cancer Center at Carolinas Medical Center, Charlotte,  North Carolina,  28232-2861,  United States; Recruiting
      Cancer Center at Iredell Memorial Hospital, Statesville,  North Carolina,  28687-1828,  United States; Recruiting
      Forsyth Regional Cancer Center at Forsyth Medical Center, Winston Salem,  North Carolina,  27103,  United States; Recruiting
      Mission Hospitals - Memorial Campus, Asheville,  North Carolina,  28801,  United States; Recruiting
      Presbyterian Cancer Center at Presbyterian Hospital, Charlotte,  North Carolina,  28233-3549,  United States; Recruiting
      Wayne Memorial Hospital, Incorporated, Goldsboro,  North Carolina,  27533,  United States; Recruiting
Ohio
      Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark,  Ohio,  43055-2899,  United States; Recruiting
      Adena Regional Medical Center, Chillicothe,  Ohio,  45601,  United States; Recruiting
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States; Recruiting
      CCOP - Dayton, Dayton,  Ohio,  45429,  United States; Recruiting
      Charles F. Kettering Memorial Hospital, Kettering,  Ohio,  45429,  United States; Recruiting
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0501,  United States; Recruiting
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195-9001,  United States; Recruiting
      Community Hospital of Springfield and Clark County, Springfield,  Ohio,  45505,  United States; Recruiting
      Community Oncology Group - Independence, Independence,  Ohio,  44131,  United States; Recruiting
      Fairfield Medical Center, Lancaster,  Ohio,  43130,  United States; Recruiting
      Good Samaritan Hospital, Dayton,  Ohio,  45406-1891,  United States; Recruiting
      Grady Memorial Hospital, Delaware,  Ohio,  43015,  United States; Recruiting
      Grandview Hospital, Dayton,  Ohio,  45405,  United States; Recruiting
      Miami Valley Hospital, Dayton,  Ohio,  45409,  United States; Recruiting
      Middletown Regional Hospital, Middletown,  Ohio,  45044-4898,  United States; Recruiting
      Riverside Methodist Hospital Cancer Care, Columbus,  Ohio,  43214-3998,  United States; Recruiting
      Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia,  Ohio,  45385,  United States; Recruiting
      Samaritan North Cancer Care Center, Dayton,  Ohio,  45415,  United States; Recruiting
      Strecker Cancer Center at Marietta Memorial Hospital, Marietta,  Ohio,  45750-1635,  United States; Recruiting
      University Hospitals Ireland Cancer Center at Mercy Medical Center, Canton,  Ohio,  44708,  United States; Recruiting
      UVMC Cancer Care Center at Upper Valley Medical Center, Troy,  Ohio,  45373-1300,  United States; Recruiting
      Veterans Affairs Medical Center - Cincinnati, Cincinnati,  Ohio,  45220-2288,  United States; Recruiting
Oregon
      Cancer Institute at Oregon Health and Science University, Portland,  Oregon,  97201-3098,  United States; Recruiting
South Carolina
      Bon Secours St. Francis Health System, Greenville,  South Carolina,  29601,  United States; Recruiting
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States; Recruiting
      Hollings Cancer Center at Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting
      McLeod Regional Medical Center, Florence,  South Carolina,  29501,  United States; Recruiting
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
      Veterans Affairs Medical Center - Amarillo, Amarillo,  Texas,  79106,  United States; Recruiting
Utah
      Huntsman Cancer Institute at University of Utah, Salt Lake City,  Utah,  84112-5550,  United States; Recruiting
Virginia
      Memorial Hospital of Martinsville and Henry County, Martinsville,  Virginia,  24115-4788,  United States; Recruiting
Washington
      Central Washington Hospital, Wenatchee,  Washington,  98801,  United States; Recruiting
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States; Recruiting
      Group Health Central Hospital, Seattle,  Washington,  98112,  United States; Recruiting
      Harborview Medical Center, Seattle,  Washington,  98104,  United States; Recruiting
      St. Joseph Hospital Community Cancer Center, Bellingham,  Washington,  98225,  United States; Recruiting
      Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle,  Washington,  98104,  United States; Recruiting
      University Cancer Center at University of Washington Medical Center, Seattle,  Washington,  98195-6043,  United States; Recruiting
      Veterans Affairs Medical Center - Seattle, Seattle,  Washington,  98108,  United States; Recruiting
      Wenatchee Valley Clinic, Wenatchee,  Washington,  98801,  United States; Recruiting

Study chairs or principal investigators

Syma Iqbal, MD,  University of Southern California   
Heinz-Josef Lenz, MD,  University of Southern California   

Study ID Numbers:  CDR0000069299; SWOG-S0202; NCT00033540
Record last reviewed:  September 2004
Last Updated:  April 5, 2005
Record first received:  April 9, 2002
ClinicalTrials.gov Identifier:  NCT00033540
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08