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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033540 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have locally advanced or metastatic gallbladder cancer or cholangiocarcinoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Extrahepatic Bile Duct Cancer Gallbladder Cancer |
Drug: capecitabine Drug: gemcitabine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients With Unresectable or Metastatic Gallbladder or Cholangiocarcinoma |
| Study Start Date: | September 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily on days 1-14 and gemcitabine IV over 100 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within approximately 10-20 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed gallbladder cancer or cholangiocarcinoma
Eligible subtypes:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
Other:
No other malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Mobile Infirmary Medical Center | |
| Mobile, Alabama, United States, 36652-2144 | |
| United States, Alaska | |
| Providence Alaska Medical Center | |
| Anchorage, Alaska, United States, 99519-6604 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| North Bay Cancer Center | |
| Fairfield, California, United States, 94533 | |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| Marin Cancer Institute at Marin General Hospital | |
| Greenbrae, California, United States, 94904 | |
| Alta Bates Comprehensive Cancer Center | |
| Berkeley, California, United States, 94704 | |
| Sutter Health Western Division Cancer Research Group | |
| Greenbrae, California, United States, 94904 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033 | |
| United States, Colorado | |
| Memorial Hospital Cancer Center | |
| Colorado Springs, Colorado, United States, 80909 | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80010 | |
| United States, Florida | |
| West Florida Regional Medical Center | |
| Pensacola, Florida, United States, 32514-6088 | |
| United States, Idaho | |
| Hematology Oncology Associates of Eastern Idaho | |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Illinois | |
| Saint Anthony's Hospital at Saint Anthony's Health Center | |
| Alton, Illinois, United States, 62002 | |
| United States, Indiana | |
| Cancer Care Center at St. Francis Hospital | |
| Indianapolis, Indiana, United States, 46237 | |
| United States, Kansas | |
| Associates in Womens Health | |
| Wichita, Kansas, United States, 67203 | |
| Cancer Center of Kansas - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| Cancer Center of Kansas - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| Cancer Center of Kansas - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Cancer Center of Kansas - McPherson | |
| McPherson, Kansas, United States, 67460 | |
| Cancer Center of Kansas - Newton | |
| Newton, Kansas, United States, 67114 | |
| Pratt Cancer Center of Kansas | |
| Pratt, Kansas, United States, 67124 | |
| Cancer Center of Kansas - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Cancer Center of Kansas - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| Cancer Center of Kansas, P.A. - Wichita | |
| Wichita, Kansas, United States, 67214-3728 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7353 | |
| Cancer Center of Kansas - Salina | |
| Salina, Kansas, United States, 67402 | |
| Salina Regional Health Center | |
| Salina, Kansas, United States, 67401 | |
| South Central Kansas Regional Medical Center | |
| Arkansas City, Kansas, United States, 67005 | |
| Southwest Medical Center | |
| Liberal, Kansas, United States, 67901 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Kentucky | |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | |
| Lexington, Kentucky, United States, 40536-0084 | |
| United States, Louisiana | |
| Cancer Center at Thibodaux Regional Medical Center | |
| Thibodaux, Louisiana, United States, 70302-1118 | |
| Cancer Treatment Center at Christus Schumpert St. Mary Place | |
| Shreveport, Louisiana, United States, 71101-0000 | |
| Louisiana State University Health Sciences Center - Monroe | |
| Monroe, Louisiana, United States, 71210 | |
| Louisiana State University Health Sciences Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| Tulane Cancer Center at Tulane University Hospital and Clinic | |
| New Orleans, Louisiana, United States, 70112 | |
| Veterans Affairs Medical Center - Shreveport | |
| Shreveport, Louisiana, United States, 71101-4295 | |
| United States, Michigan | |
| Hackley Hospital | |
| Muskegon, Michigan, United States, 49443-3302 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| Battle Creek Health System | |
| Battle Creek, Michigan, United States, 49016 | |
| Holland Community Hospital | |
| Holland, Michigan, United States, 49423 | |
| Josephine Ford Cancer Center at Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| Lacks Cancer Center at Saint Mary's Mercy Medical Center | |
| Grand Rapids, Michigan, United States, 49503 | |
| Mecosta County General Hospital | |
| Big Rapids, Michigan, United States, 49307 | |
| Northern Michigan Hospital | |
| Petoskey, Michigan, United States, 49770 | |
| Munson Medical Center | |
| Traverse City, Michigan, United States, 49684 | |
| Metropolitan Hospital | |
| Grand Rapids, Michigan, United States, 49506 | |
| Spectrum Health Cancer Care - Butterworth Campus | |
| Grand Rapids, Michigan, United States, 49503 | |
| Spectrum Health Hospital - Blodgett Campus | |
| Grand Rapids, Michigan, United States, 49506 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| CCOP - St. Louis-Cape Girardeau | |
| Saint Louis, Missouri, United States, 63141 | |
| Hulston Cancer Center at Cox Medical Center South | |
| Springfield, Missouri, United States, 65807 | |
| David C. Pratt Cancer Center at St. John's Mercy | |
| Saint Louis, Missouri, United States, 63141 | |
| Center for Cancer Care and Research | |
| Saint Louis, Missouri, United States, 63141 | |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | |
| Cape Girardeau, Missouri, United States, 63701 | |
| St. Francis Medical Center | |
| Cape Girardeau, Missouri, United States, 63701 | |
| St. John's Regional Health Center | |
| Springfield, Missouri, United States, 65804-2263 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Great Falls Clinic | |
| Great Falls, Montana, United States, 59403 | |
| Sletten Regional Cancer Institute | |
| Great Falls, Montana, United States, 59405 | |
| United States, New Mexico | |
| Veterans Affairs Medical Center - Albuquerque | |
| Albuquerque, New Mexico, United States, 87108-5138 | |
| United States, New York | |
| Adirondack Cancer Care | |
| Glens Falls, New York, United States, 12801 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Orange Regional Medical Center - Horton Campus | |
| Middletown, New York, United States, 10940-4199 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Mission Hospitals - Memorial Campus | |
| Asheville, North Carolina, United States, 28801 | |
| Forsyth Regional Cancer Center at Forsyth Medical Center | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Cancer Center at Iredell Memorial Hospital | |
| Statesville, North Carolina, United States, 28687-1828 | |
| Presbyterian Cancer Center at Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Wayne Memorial Hospital, Incorporated | |
| Goldsboro, North Carolina, United States, 27533 | |
| United States, Ohio | |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | |
| Newark, Ohio, United States, 43055-2899 | |
| Adena Regional Medical Center | |
| Chillicothe, Ohio, United States, 45601 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195-9001 | |
| Community Hospital of Springfield and Clark County | |
| Springfield, Ohio, United States, 45505 | |
| Community Oncology Group - Independence | |
| Independence, Ohio, United States, 44131 | |
| Fairfield Medical Center | |
| Lancaster, Ohio, United States, 43130 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406-1891 | |
| Charles M. Barrett Cancer Center at University Hospital | |
| Cincinnati, Ohio, United States, 45267-0501 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| Middletown Regional Hospital | |
| Middletown, Ohio, United States, 45044-4898 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214-3998 | |
| Strecker Cancer Center at Marietta Memorial Hospital | |
| Marietta, Ohio, United States, 45750-1635 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| University Hospitals Ireland Cancer Center at Mercy Medical Center | |
| Canton, Ohio, United States, 44708 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373-1300 | |
| Veterans Affairs Medical Center - Cincinnati | |
| Cincinnati, Ohio, United States, 45220-2288 | |
| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97201-3098 | |
| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| Bon Secours St. Francis Health System | |
| Greenville, South Carolina, United States, 29601 | |
| McLeod Regional Medical Center | |
| Florence, South Carolina, United States, 29501 | |
| United States, Texas | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Veterans Affairs Medical Center - Amarillo | |
| Amarillo, Texas, United States, 79106 | |
| United States, Utah | |
| Huntsman Cancer Institute at University of Utah | |
| Salt Lake City, Utah, United States, 84112-5550 | |
| United States, Virginia | |
| Memorial Hospital of Martinsville and Henry County | |
| Martinsville, Virginia, United States, 24115-4788 | |
| United States, Washington | |
| Central Washington Hospital | |
| Wenatchee, Washington, United States, 98801 | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Wenatchee Valley Clinic | |
| Wenatchee, Washington, United States, 98801 | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| St. Joseph Hospital Community Cancer Center | |
| Bellingham, Washington, United States, 98225 | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |
| Seattle, Washington, United States, 98104 | |
| University Cancer Center at University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| Veterans Affairs Medical Center - Seattle | |
| Seattle, Washington, United States, 98108 | |
| Group Health Central Hospital | |
| Seattle, Washington, United States, 98112 | |
| Investigator: | Syma Iqbal, MD | USC/Norris Comprehensive Cancer Center |
| Investigator: | Heinz-Josef Lenz, MD | USC/Norris Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000069299, SWOG-S0202 |
| Study First Received: | April 9, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00033540 History of Changes |
| Health Authority: | United States: Federal Government |
|
unresectable gallbladder cancer recurrent gallbladder cancer unresectable extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer adenocarcinoma of the gallbladder |
adenocarcinoma with squamous metaplasia of the gallbladder squamous cell carcinoma of the gallbladder adenocarcinoma of the extrahepatic bile duct cholangiocarcinoma of the gallbladder cholangiocarcinoma of the extrahepatic bile duct |
|
Gallbladder Diseases Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Biliary Tract Diseases Therapeutic Uses Gemcitabine Cholangiocarcinoma Capecitabine Digestive System Neoplasms |
Biliary Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Bile Duct Diseases Bile Duct Neoplasms Gallbladder Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial |