S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct

Not Recruiting

Trial ID: NCT00789958


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.

Official Title

A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed By Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)

Stanford Investigator(s)

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine



   - 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


   - 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

      - 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

   - 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


   - See Disease Characteristics

   - No prior chemotherapy or radiotherapy for this disease

   - No prior upper abdominal radiotherapy


radiation: 3-dimensional conformal radiation therapy

radiation: intensity-modulated radiation therapy

drug: capecitabine

drug: gemcitabine hydrochloride

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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