A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed By Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)
A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed By Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)
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.
OBJECTIVES:
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)
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:
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
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:
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:
Little Rock, Arkansas 72205, United States
Los Angeles, California 90089-9181, United States
Orange, California 92868, United States
Aurora, Colorado 80045, United States
Grand Junction, Colorado 81502, United States
Washington D.C., District of Columbia 20007, United States
Washington D.C., District of Columbia 20010, United States
Chicago, Illinois 60611-3013, United States
Libertyville, Illinois 60048, United States
Maywood, Illinois 60153, United States
Beech Grove, Indiana 46107, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Kansas City, Kansas 66160-7357, United States
Wichita, Kansas 67214, United States
Baltimore, Maryland 21231-2410, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Billings, Montana 59102, United States
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Basking Ridge, New Jersey 07920, United States
Marlton, New Jersey 08053, United States
Voorhees Township, New Jersey 08043, United States
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East Syracuse, New York 13057, United States
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Rockville Centre, New York 11570, United States
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Charlotte, North Carolina 28232-2861, United States
Charlotte, North Carolina 28233-3549, United States
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Murray, Utah 84157, United States
Seattle, Washington 98122-4307, United States
Seattle, Washington 98195, United States