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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 CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
University of Chicago Cancer Research CenterChicago, Illinois  60637
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
CCOP - Colorado Cancer Research ProgramDenver, Colorado  80224-2522
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado  81502
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
St. Mary - Corwin Regional Medical CenterPueblo, Colorado  81004
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - OchsnerNew Orleans, Louisiana  70121
Kaiser Permanente Medical Center - Los AngelesLos Angeles, California  90027
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - DaytonKettering, Ohio  45429
LDS HospitalSalt Lake City, Utah  84143
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Medical Center of Central GeorgiaMacon, Georgia  31201
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Lahey Clinic Medical Center - BurlingtonBurlington, Massachusetts  01805
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Peninsula Medical CenterBurlingame, California  94010
Sutter Health - Western Division Cancer Research GroupGreenbrae, California  94904
California Pacific Medical Center - California CampusSan Francisco, California  94118
Sutter Solano Medical CenterVallejo, California  94589
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Piedmont HospitalAtlanta, Georgia  30309
WellStar Cobb HospitalAustell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Gwinnett Medical CenterLawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone HospitalMarietta, Georgia  30060
Southern Regional Medical CenterRiverdale, Georgia  30274-2600
Hematology and Oncology AssociatesChicago, Illinois  60611
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
Edward Hospital Cancer CenterNaperville, Illinois  60540
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Lima Memorial HospitalLima, Ohio  45804
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Middletown Regional HospitalMiddletown, Ohio  45044
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Fulton County Health CenterWauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Danville Regional Medical CenterDanville, Virginia  24541
Polyclinic First HillSeattle, Washington  98122
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
St. Anthony Central HospitalDenver, Colorado  80204-1335
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
John B. Amos Cancer CenterColumbus, Georgia  31904
Harbin Clinic Cancer Center - Medical OncologyRome, Georgia  30165
Kellogg Cancer Care CenterHighland Park, Illinois  60035
Cancer Care and Hematology Specialists of Chicagoland - NilesNiles, Illinois  60714
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Mercy Memorial Hospital - MonroeMonroe, Michigan  48162
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Truman Medical Center - Hospital HillKansas City, Missouri  64108
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
Hematology Oncology CenterElyria, Ohio  44035
Community Cancer CenterElyria, Ohio  44035
Wayne HospitalGreenville, Ohio  45331
Flower Hospital Cancer CenterSylvania, Ohio  43560
St. Anne Mercy HospitalToledo, Ohio  43623
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
Fredericksburg Oncology, IncorporatedFredericksburg, Virginia  22401
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Harrison Poulsbo Hematology and OnocologyPoulsbo, Washington  98370
Evergreen Hematology and Oncology, PSSpokane, Washington  99218
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Boston University Cancer Research CenterBoston, Massachusetts  02118
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Lynchburg Hematology-Oncology ClinicLynchburg, Virginia  24501
AnMed Cancer CenterAnderson, South Carolina  29621
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Regional Medical CenterAnniston, Alabama  36202
Provena St. Mary's Regional Cancer Center - KankakeeKankakee, Illinois  60901
Minnesota Oncology - MaplewoodMaplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Minnesota Oncology - WoodburyWoodbury, Minnesota  55125
Mount Carmel Regional Cancer CenterPittsburg, Kansas  66762
Northwest Cancer Specialists at Vancouver Cancer CenterVancouver, Washington  98684
Shaw Regional Cancer CenterEdwards, Colorado  81632
Kansas City Cancer Centers - SouthwestOverland Park, Kansas  66210
Piedmont Fayette HospitalFayetteville, Georgia  30214
Hays Medical CenterHays, Kansas  67601
Hutchinson Hospital CorporationHutchinson, Kansas  67502
Clackamas Radiation Oncology CenterClackamas, Oregon  97015
Providence Newberg Medical CenterNewberg, Oregon  97132
Willamette Falls HospitalOregon City, Oregon  97045
Island Hospital Cancer Care Center at Island HospitalAnacortes, Washington  98221
Highline Medical Center Cancer CenterBurien, Washington  98166
Littleton Adventist HospitalLittleton, Colorado  80122
Parker Adventist HospitalParker, Colorado  80138
New Ulm Medical CenterNew Ulm, Minnesota  56073
Kansas City Cancer Centers - NorthKansas City, Missouri  64154
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy Hollow, New York  10591
Kansas City Cancer Centers - SouthKansas City, Missouri  64131
St. Rose Ambulatory and Surgery CenterGreat Bend, Kansas  67530
Kansas City Cancer Centers - WestKansas City, Kansas  66112
Kansas City Cancer Center - Shawnee MissionShawnee Mission, Kansas  66204
Kansas City Cancer Centers - EastLee's Summit, Missouri  64064
Cancer Center of Kansas, PA - McPhersonMcPherson, Kansas  67460
Swedish Medical Center - Issaquah CampusIssaquah, Washington  98029
Memorial Sloan-Kettering Cancer Center - Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center - Rockville CentreRockville Centre, New York  11570
Sutter Pacific Medical FoundationSanta Rosa, California  95403