Adjuvant Palliative Capecitabine and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Biliary Tract Cancer
Condition: Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer; Pain
MeSH terms: Liver Neoplasms; Biliary Tract Neoplasms; Gallbladder Neoplasms; Bile Duct Neoplasms; Cholangiocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, use different
      ways to stop tumor cells from dividing so they stop growing or die. Palliative chemotherapy
      may improve the quality of life in patients who have locally advanced or metastatic biliary
      tract cancer and may help them live more comfortably.

      PURPOSE: Phase II trial to study the effectiveness of adjuvant capecitabine and gemcitabine
      in improving quality of life in patients who have locally advanced or metastatic biliary
      tract cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the ability of palliative capecitabine and gemcitabine to maintain or improve
           tumor-related symptoms (after treatable biliary duct obstruction has been relieved) as
           measured by the clinical benefit response in patients with locally advanced or
           metastatic biliary tract cancer.

      Secondary

        -  Determine the clinical benefit response in patients treated with this regimen.

        -  Determine the time to and duration of clinical benefit response in patients treated with
           this regimen.

        -  Determine the objective response and time to progression in patients treated with this
           regimen.

        -  Determine the overall survival of patients treated with this regimen.

        -  Determine the quality of life of patients treated with this regimen.

        -  Determine the adverse events in patients treated with this regimen.

      OUTLINE: This is an open-label, multicenter study.

      Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice
      daily on days 1-14 (28 total doses). Treatment repeats every 21 days for 8 courses in the
      absence of disease progression or unacceptable toxicity. Patients responding to treatment may
      receive additional courses at the discretion of the investigator.

      Quality of life is assessed at baseline, weekly during weeks 2-9 (courses 1-3), and then
      before each administration of gemcitabine.

      Patients are followed every 3 months for 1 year and then every 6 months thereafter.

      PROJECTED ACCRUAL: A total of 19-44 patients will be accrued for this study within 3 years.
    

Intervention name(s): capecitabine plus gemcitabine
Intervention type(s): Drug
Intervention description(s): capecitabine plus gemcitabine
Intervention MeSH terms: Gemcitabine; Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: unresectable gallbladder cancer; adenocarcinoma of the gallbladder; adenocarcinoma of the extrahepatic bile duct; unresectable extrahepatic bile duct cancer; pain; recurrent gallbladder cancer; recurrent extrahepatic bile duct cancer; localized unresectable adult primary liver cancer; advanced adult primary liver cancer; recurrent adult primary liver cancer