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

OBJECTIVES:

- To estimate the stratum-specific (R0 and R1) and overall 2-year survival probabilities
of patients with extrahepatic cholangiocarcinoma treated with adjuvant chemotherapy
comprising capecitabine and gemcitabine hydrochloride, followed by capecitabine and
radiotherapy. (R0 stratum closed as of 12-15-11)

- To estimate the 2-year stratum-specific and overall disease-free survival and local
disease-free survival of patients treated with this regimen.

- To assess the frequency and severity of toxicity in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to margin of
resection (negative [R0] vs microscopically positive [R1]). (R0 stratum closed as of
12-15-11)

- Adjuvant chemotherapy: Patients receive oral capecitabine every 12 hours on days 1-14
and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats
every 21 days for 4 courses in the absence of disease progression or unacceptable
toxicity.

- Chemoradiotherapy: Beginning in week 13, patients receive oral capecitabine every 12
hours on days 1-7. Patients also undergo concurrent three-dimensional or
intensity-modulated radiotherapy on days 1-5. Treatment repeats weekly for 5-6 weeks in
the absence of disease progression or unacceptable toxicity.

After completion of study therapy patients are followed periodically for up to 5 years.

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