S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma
- Conditions
- Extrahepatic Bile Duct CancerGallbladder Cancer
- Interventions
- Registration Number
- NCT00033540
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Capecitabine + Gemcitabine gemcitabine hydrochloride Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days Capecitabine + Gemcitabine capecitabine Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
- Primary Outcome Measures
Name Time Method Response Patients assessed at least every six weeks while on protocol treatment 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.
- Secondary Outcome Measures
Name Time Method Overall Survival All patients will be followed until death or three years after registration, whichever is first. Measured from time of registration to death, or last contact date
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. For each patient, worst grade of each event type is reported.
Accrual of Patients With This Disease Site 1-20 months Only eligible patients who received treatment were evaluable for response and survival outcomes.
Median Survival Time for Participants With Relevant Biologic Markers All patients will be followed until death or three years after registration, whichever is first. To evaluate in a preliminary fashion relevant prognostic markers in gallbladder and cholangiocarcinoma which may have prognostic implications as predictors of survival. Overall survival measured from time of registration to death, or last contact date.
Trial Locations
- Locations (112)
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
North Bay Cancer Center
🇺🇸Fairfield, California, United States
Hematology Oncology Associates of Eastern Idaho
🇺🇸Idaho Falls, Idaho, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Sletten Regional Cancer Institute
🇺🇸Great Falls, Montana, United States
Mission Hospitals - Memorial Campus
🇺🇸Asheville, North Carolina, United States
Cancer Center at Iredell Memorial Hospital
🇺🇸Statesville, North Carolina, United States
University Hospitals Ireland Cancer Center at Mercy Medical Center
🇺🇸Canton, Ohio, United States
Wenatchee Valley Clinic
🇺🇸Wenatchee, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Orange Regional Medical Center - Horton Campus
🇺🇸Middletown, New York, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
🇺🇸Cape Girardeau, Missouri, United States
Adirondack Cancer Care
🇺🇸Glens Falls, New York, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
South Central Kansas Regional Medical Center
🇺🇸Arkansas City, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas - Kingman
🇺🇸Kingman, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas - McPherson
🇺🇸McPherson, Kansas, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Cancer Center of Kansas - Newton
🇺🇸Newton, Kansas, United States
Pratt Cancer Center of Kansas
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas - Salina
🇺🇸Salina, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas - Dodge City
🇺🇸Dodge City, Kansas, United States
Center for Cancer Care and Research
🇺🇸Saint Louis, Missouri, United States
St. Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Community Oncology Group - Independence
🇺🇸Independence, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Central Washington Hospital
🇺🇸Wenatchee, Washington, United States
Memorial Hospital of Martinsville and Henry County
🇺🇸Martinsville, Virginia, United States
St. Joseph Hospital Community Cancer Center
🇺🇸Bellingham, Washington, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
McLeod Regional Medical Center
🇺🇸Florence, South Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Veterans Affairs Medical Center - Amarillo
🇺🇸Amarillo, Texas, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
Josephine Ford Cancer Center at Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Marin Cancer Institute at Marin General Hospital
🇺🇸Greenbrae, California, United States
Sutter Health Western Division Cancer Research Group
🇺🇸Greenbrae, California, United States
Cancer Care Center at St. Francis Hospital
🇺🇸Indianapolis, Indiana, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
🇺🇸Alton, Illinois, United States
West Florida Regional Medical Center
🇺🇸Pensacola, Florida, United States
Memorial Hospital Cancer Center
🇺🇸Colorado Springs, Colorado, United States
Associates in Womens Health
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas - Winfield
🇺🇸Winfield, Kansas, United States
Louisiana State University Health Sciences Center - Monroe
🇺🇸Monroe, Louisiana, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Tulane Cancer Center at Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
Battle Creek Health System
🇺🇸Battle Creek, Michigan, United States
Cancer Treatment Center at Christus Schumpert St. Mary Place
🇺🇸Shreveport, Louisiana, United States
Cancer Center at Thibodaux Regional Medical Center
🇺🇸Thibodaux, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Mecosta County General Hospital
🇺🇸Big Rapids, Michigan, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Mercy Medical Center
🇺🇸Grand Rapids, Michigan, United States
Spectrum Health Cancer Care - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Metropolitan Hospital
🇺🇸Grand Rapids, Michigan, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Holland Community Hospital
🇺🇸Holland, Michigan, United States
Spectrum Health Hospital - Blodgett Campus
🇺🇸Grand Rapids, Michigan, United States
Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸Saint Louis, Missouri, United States
Hackley Hospital
🇺🇸Muskegon, Michigan, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Bon Secours St. Francis Health System
🇺🇸Greenville, South Carolina, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Cancer Center of Kansas, P.A. - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Cancer Center of Kansas - Wellington
🇺🇸Wellington, Kansas, United States