A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients With Unresectable or Metastatic Gallbladder or Cholangiocarcinoma
OBJECTIVES:
- Determine the response rates (confirmed complete and partial responses) in patients
with unresectable, locally advanced or metastatic gallbladder cancer or
cholangiocarcinoma treated with gemcitabine and capecitabine.
- Determine the overall survival of patients treated with this regimen.
- Determine the quantitative and qualitative toxic effects of this regimen in these
patients.
- Determine the feasibility of accruing patients with these disease sites.
- Evaluate, preliminarily, relevant prognostic markers in these disease sites and the
prognostic implications as predictors of survival in patients treated with this
regimen.
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response
Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Patients assessed at least every six weeks while on protocol treatment
No
Syma Iqbal, MD
Study Chair
USC/Norris Comprehensive Cancer Center
United States: Federal Government
CDR0000069299
NCT00033540
September 2003
July 2011
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
Sutter Health Western Division Cancer Research Group | Greenbrae, California 94904 |
Memorial Hospital Cancer Center | Colorado Springs, Colorado 80909 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Greenville | Greenville, South Carolina 29615 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
Providence Alaska Medical Center | Anchorage, Alaska 99508 |
Veterans Affairs Medical Center - Amarillo | Amarillo, Texas 79106 |
Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
Great Falls Clinic | Great Falls, Montana 59405 |
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 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans, Louisiana 70112 |
Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
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 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Spectrum Health Cancer Care - Butterworth Campus | Grand Rapids, Michigan 49503-2560 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Kingman | Kingman, Kansas 67068 |
Southwest Medical Center | Liberal, Kansas 67901 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Pratt Cancer Center of Kansas | Pratt, Kansas 67124 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas, P.A. - Wichita | Wichita, Kansas 67214 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Mecosta County General Hospital | Big Rapids, Michigan 49307 |
Metropolitan Hospital | Grand Rapids, Michigan 49506 |
Lacks Cancer Center at Saint Mary's Mercy Medical Center | Grand Rapids, Michigan 49503 |
Holland Community Hospital | Holland, Michigan 49423 |
Hackley Hospital | Muskegon, Michigan 49443 |
Northern Michigan Hospital | Petoskey, Michigan 49770 |
Munson Medical Center | Traverse City, Michigan 49684 |
St. Francis Medical Center | Cape Girardeau, Missouri 63701 |
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Sletten Regional Cancer Institute | Great Falls, Montana 59405 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
St. Joseph Hospital Community Cancer Center | Bellingham, Washington 98225 |
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 |
Central Washington Hospital | Wenatchee, Washington 98801 |
Wenatchee Valley Clinic | Wenatchee, Washington 98801 |
Josephine Ford Cancer Center at Henry Ford Health System | Detroit, Michigan 48202 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
North Bay Cancer Center | Fairfield, California 94533 |
Marin Cancer Institute at Marin General Hospital | Greenbrae, California 94904 |
Salina Regional Health Center | Salina, Kansas 67401 |
Louisiana State University Health Sciences Center - Monroe | Monroe, Louisiana 71210 |
Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem, North Carolina 27103 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
Community Oncology Group - Independence | Independence, Ohio 44131 |
South Central Kansas Regional Medical Center | Arkansas City, Kansas 67005 |
Battle Creek Health System | Battle Creek, Michigan 49017 |
Spectrum Health Hospital - Blodgett Campus | Grand Rapids, Michigan 49506 |
Center for Cancer Care and Research | St. Louis, Missouri 63141 |
University Hospitals Ireland Cancer Center at Mercy Medical Center | Canton, Ohio 44708 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Hematology Oncology Associates of Eastern Idaho | Idaho Falls, Idaho 83404 |
West Florida Regional Medical Center | Pensacola, Florida 32514-6088 |
Cancer Treatment Center at Christus Schumpert St. Mary Place | Shreveport, Louisiana 71101 |
Cancer Center at Iredell Memorial Hospital | Statesville, North Carolina 28687-1828 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
Orange Regional Medical Center - Horton Campus | Middletown, New York 10940-4199 |
Cancer Care Center at St. Francis Hospital | Indianapolis, Indiana 46237 |
Cancer Center of Kansas - McPherson | McPherson, Kansas 67460 |
Cancer Center at Thibodaux Regional Medical Center | Thibodaux, Louisiana 70302-1118 |
Adirondack Cancer Care | Glens Falls, New York 12801 |
Memorial Hospital of Martinsville and Henry County | Martinsville, Virginia 24115-4788 |