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



Status:Completed
Conditions:Liver Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:4/17/2018
Start Date:December 2008
End Date:December 2017

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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:

- 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
We found this trial at
253
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100 Provena Way
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Baltimore, Maryland 21231
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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2720 Clare Avenue
Bremerton, Washington 98310
360-479-6154
Olympic Hematology and Oncology We provide outpatient cancer services in a refined environment designed specifically...
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86 Jonathan Lucas Street
Charleston, South Carolina 29425
(843) 792-0700
Hollings Cancer Center at Medical University of South Carolina Located at the Medical University of...
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1025 Morehead Medical Dr # 600
Charlotte, North Carolina 28204
(704) 355-2884
Blumenthal Cancer Center at Carolinas Medical Center As our patients wage their personal wars against...
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200 Hawthorne Lane
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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1719 East 19th Avenue
Denver, Colorado 80218
(303) 839-6000
Presbyterian - St. Luke's Medical Center Presbyterian/St. Luke's Medical Center and the Rocky Mountain Hospital...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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2500 N. State St.
Jackson, Mississippi 39216
(601) 815-6802
University of Mississippi Cancer Clinic he Cancer Institute is home to the ACT Tobacco Treatment,...
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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902 Savannah Road
Lewes, Delaware 19958
(302) 645-3770
Tunnell Cancer Center at Beebe Medical Center The Robert & Eolyne Tunnell Cancer Center at...
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777 Hemlock Street
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(478) 633-1000
Medical Center of Central Georgia Navicent Health is a designated Level I Trauma Center and...
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1415 E. Kincaid
Mount Vernon, Washington 98273
360-424-4111
Skagit Valley Hospital Cancer Care Center We know that treatment takes its toll physically, emotionally...
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19500 10th Ave NE # 100
Poulsbo, Washington 98370
(360) 598-7500
Harrison Poulsbo Hematology and Onocology Harrison Poulsbo's new Hematology & Oncology center provides outpatient cancer...
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201 16th Avenue East
Seattle, Washington 98112
(206) 326-3000
Group Health Central Hospital Group Health Cooperative is a member-governed, nonprofit health care system that...
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1100 Fairview Avenue North
Seattle, Washington 98109
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1959 NE Pacific St
Seattle, Washington 98195
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University Cancer Center at University of Washington Medical Center The Division of Radiation Oncology's work...
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747 Broadway
Seattle, Washington 98122
206-386-6000
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Since 1910, Swedish has...
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601 South Sherman Street
Spokane, Washington 99202
(509) 228-1000
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750 E Adams St
Syracuse, New York 13210
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820 North Chelan Avenue
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825 N Emporia Ave
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(316) 261-3200
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777 Kimole Ln
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161 North Forge Street
Akron, Ohio 44304
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1500 East Medical Center Drive
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5665 Peachtree Dunwoody Rd NE
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1968 Peachtree Rd NW
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Austell, Georgia 30106
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136 Mountainview Blvd
Basking Ridge, New Jersey 7920
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8111 South Emerson Avenue
Beech Grove, Indiana 46237
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3301 Squalicum Parkway
Bellingham, Washington 98225
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2450 Ashby Ave.
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2900 12th Ave N Ste 160W
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Hematology-Oncology Centers of the Northern Rockies - Billings The physicians and staff of Hematology-Oncology Centers...
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1101 N 27th St # 201
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720 E Rosser Ave
Bismarck, North Dakota 58501
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900 East Broadway
Bismarck, North Dakota 58501
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St. Alexius Medical Center Cancer Center Throughout the healing continuum we are dedicated to our...
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72 East Concord St.
Boston, Massachusetts 02118
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1100 Balsam Ave
Boulder, Colorado 80304
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931 Highland Blvd
Bozeman, Montana 59715
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Bozeman Deaconess Cancer Center Bozeman Deaconess Cancer Center provides the latest cancer technologies and treatment...
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16233 Sylvester Rd SW #110
Burien, Washington 98166
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Burlingame, California 94010
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
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400 S Clark St
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6501 E 2nd St
Casper, Wyoming 82609
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1303 North Main Street
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505 S Plummer Ave
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676 N St Clair St #2140
Chicago, Illinois 60611
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
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11850 Blackfoot St. NW Suite 130
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142 S Main St
Danville, Virginia 24541
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1221 Pleasant St Suite 100
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1221 Pleasant St Suite 100
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6401 France Ave S
Edina, Minnesota 55435
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41201 Schadden Rd
Elyria, Ohio 44035
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