Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT00789958

S0809: Capecitabine, Gemcitabine, and RT in Patients w/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)

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

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

Disease(s) and\or Condition(s)

Extrahepatic Bile Duct Cancer

Gallbladder Cancer

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: capecitabine
    • 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
    • Arm Group Labels: Adjuvant Chemo+ Chemoradiotherapy
    • Type: DRUG
    • Name: gemcitabine hydrochloride
    • Description: 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle
    • Arm Group Labels: Adjuvant Chemo+ Chemoradiotherapy
    • Type: RADIATION
    • Name: 3-dimensional conformal radiation therapy
    • Description: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions.
    • Arm Group Labels: Adjuvant Chemo+ Chemoradiotherapy
    • Type: RADIATION
    • Name: intensity-modulated radiation therapy
    • Description: 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.
    • Arm Group Labels: Adjuvant Chemo+ Chemoradiotherapy
Sponsor
  • SWOG Cancer Research Network