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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Extrahepatic Bile Duct Cancer, Gallbladder Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Stratum-specific (R0 vs R1) and overall 2-year survival (R0 stratum closed as of 12-15-11, R1 closed as of 10-1-12)

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Edgar Ben-Josef, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000619334

NCT ID:

NCT00789958

Start Date:

December 2008

Completion Date:

December 2017

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • cholangiocarcinoma of the extrahepatic bile duct
  • cholangiocarcinoma of the gallbladder
  • localized extrahepatic bile duct cancer
  • localized gallbladder cancer
  • unresectable extrahepatic bile duct cancer
  • unresectable gallbladder cancer
  • metastatic extrahepatic bile duct cancer
  • metastatic gallbladder cancer
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Cholangiocarcinoma

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
University of Chicago Cancer Research Center Chicago, Illinois  60637
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Aurora Presbyterian Hospital Aurora, Colorado  80012
Boulder Community Hospital Boulder, Colorado  80301-9019
Penrose Cancer Center at Penrose Hospital Colorado Springs, Colorado  80933
CCOP - Colorado Cancer Research Program Denver, Colorado  80224-2522
Porter Adventist Hospital Denver, Colorado  80210
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
St. Joseph Hospital Denver, Colorado  80218
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction, Colorado  81502
Sky Ridge Medical Center Lone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United Hospital Longmont, Colorado  80502
St. Mary - Corwin Regional Medical Center Pueblo, Colorado  81004
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
CCOP - Ochsner New Orleans, Louisiana  70121
Kaiser Permanente Medical Center - Los Angeles Los Angeles, California  90027
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Dayton Kettering, Ohio  45429
LDS Hospital Salt Lake City, Utah  84143
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology Program Portland, Oregon  97225
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Medical Center of Central Georgia Macon, Georgia  31201
St. Vincent Mercy Medical Center Toledo, Ohio  43608
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Northside Hospital Cancer Center Atlanta, Georgia  30342-1611
Washington Cancer Institute at Washington Hospital Center Washington, District of Columbia  20010
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans, Louisiana  70121
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Lahey Clinic Medical Center - Burlington Burlington, Massachusetts  01805
CCOP - Hematology-Oncology Associates of Central New York East Syracuse, New York  13057
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
North Puget Oncology at United General Hospital Sedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees, New Jersey  08043
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Hematology Oncology Associates - Skokie Skokie, Illinois  60076
UPMC Cancer Centers Pittsburgh, Pennsylvania  15232
Peninsula Medical Center Burlingame, California  94010
Sutter Health - Western Division Cancer Research Group Greenbrae, California  94904
California Pacific Medical Center - California Campus San Francisco, California  94118
Sutter Solano Medical Center Vallejo, California  94589
Saint Joseph's Hospital of Atlanta Atlanta, Georgia  30342-1701
Piedmont Hospital Atlanta, Georgia  30309
WellStar Cobb Hospital Austell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur, Georgia  30033
Gwinnett Medical Center Lawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta, Georgia  30060
Southern Regional Medical Center Riverdale, Georgia  30274-2600
Hematology and Oncology Associates Chicago, Illinois  60611
North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville, Illinois  60048
Edward Hospital Cancer Center Naperville, Illinois  60540
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des Moines West Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
St. Francis Comprehensive Cancer Center Topeka, Kansas  66606
Hickman Cancer Center at Bixby Medical Center Adrian, Michigan  49221
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Lima Memorial Hospital Lima, Ohio  45804
Northwest Ohio Oncology Center Maumee, Ohio  43537
Middletown Regional Hospital Middletown, Ohio  45044
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Fulton County Health Center Wauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Danville Regional Medical Center Danville, Virginia  24541
Polyclinic First Hill Seattle, Washington  98122
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
St. Anthony Central Hospital Denver, Colorado  80204-1335
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Alta Bates Summit Comprehensive Cancer Center Berkeley, California  94704
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
John B. Amos Cancer Center Columbus, Georgia  31904
Harbin Clinic Cancer Center - Medical Oncology Rome, Georgia  30165
Kellogg Cancer Care Center Highland Park, Illinois  60035
Cancer Care and Hematology Specialists of Chicagoland - Niles Niles, Illinois  60714
Reid Hospital & Health Care Services Richmond, Indiana  47374
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Liberal Liberal, Kansas  67905
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
Willmar Cancer Center at Rice Memorial Hospital Willmar, Minnesota  56201
Truman Medical Center - Hospital Hill Kansas City, Missouri  64108
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Barberton Citizens Hospital Barberton, Ohio  44203
Hematology Oncology Center Elyria, Ohio  44035
Community Cancer Center Elyria, Ohio  44035
Wayne Hospital Greenville, Ohio  45331
Flower Hospital Cancer Center Sylvania, Ohio  43560
St. Anne Mercy Hospital Toledo, Ohio  43623
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden, Utah  84403
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
St. Joseph Cancer Center Bellingham, Washington  98225
Columbia Basin Hematology Kennewick, Washington  99336
Harrison Poulsbo Hematology and Onocology Poulsbo, Washington  98370
Evergreen Hematology and Oncology, PS Spokane, Washington  99218
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Rocky Mountain Oncology Casper, Wyoming  82609
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Tucker Center for Cancer Care at Orange Regional Medical Center Middletown, New York  10940-4199
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Union Hospital of Cecil County Elkton MD, Maryland  21921
Boston University Cancer Research Center Boston, Massachusetts  02118
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Lynchburg Hematology-Oncology Clinic Lynchburg, Virginia  24501
AnMed Cancer Center Anderson, South Carolina  29621
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Regional Medical Center Anniston, Alabama  36202
Provena St. Mary's Regional Cancer Center - Kankakee Kankakee, Illinois  60901
Minnesota Oncology - Maplewood Maplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
Lakeview Hospital Stillwater, Minnesota  55082
Minnesota Oncology - Woodbury Woodbury, Minnesota  55125
Mount Carmel Regional Cancer Center Pittsburg, Kansas  66762
Northwest Cancer Specialists at Vancouver Cancer Center Vancouver, Washington  98684
Shaw Regional Cancer Center Edwards, Colorado  81632
Kansas City Cancer Centers - Southwest Overland Park, Kansas  66210
Piedmont Fayette Hospital Fayetteville, Georgia  30214
Hays Medical Center Hays, Kansas  67601
Hutchinson Hospital Corporation Hutchinson, Kansas  67502
Clackamas Radiation Oncology Center Clackamas, Oregon  97015
Providence Newberg Medical Center Newberg, Oregon  97132
Willamette Falls Hospital Oregon City, Oregon  97045
Island Hospital Cancer Care Center at Island Hospital Anacortes, Washington  98221
Highline Medical Center Cancer Center Burien, Washington  98166
Littleton Adventist Hospital Littleton, Colorado  80122
Parker Adventist Hospital Parker, Colorado  80138
New Ulm Medical Center New Ulm, Minnesota  56073
Kansas City Cancer Centers - North Kansas City, Missouri  64154
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Sleepy Hollow, New York  10591
Kansas City Cancer Centers - South Kansas City, Missouri  64131
St. Rose Ambulatory and Surgery Center Great Bend, Kansas  67530
Kansas City Cancer Centers - West Kansas City, Kansas  66112
Kansas City Cancer Center - Shawnee Mission Shawnee Mission, Kansas  66204
Kansas City Cancer Centers - East Lee's Summit, Missouri  64064
Cancer Center of Kansas, PA - McPherson McPherson, Kansas  67460
Swedish Medical Center - Issaquah Campus Issaquah, Washington  98029
Memorial Sloan-Kettering Cancer Center - Basking Ridge Basking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center - Rockville Centre Rockville Centre, New York  11570
Sutter Pacific Medical Foundation Santa Rosa, California  95403