S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct
Condition: Extrahepatic Bile Duct Cancer; Gallbladder Cancer
MeSH terms: Cholangiocarcinoma; Gallbladder Neoplasms; Bile Duct Neoplasms
Intervention: capecitabine; gemcitabine hydrochloride; 3-dimensional conformal radiation therapy; intensity-modulated radiation therapy
Intervention description: Adjuvant chemotherapy: 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle
Chemoradiotherapy: 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; 1000 mg/m^2, IV, Days 1 & 8 of each cycle; 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions.; 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.
Intervention MeSH terms: Gemcitabine; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: 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

Summary:

      RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.
      Specialized radiation therapy that delivers a high dose of radiation directly to the tumor
      may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug
      (combination chemotherapy) together with radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving capecitabine together with
      gemcitabine followed by capecitabine and radiation therapy works in treating patients with
      cholangiocarcinoma of the gallbladder or bile duct.
    

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