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S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma

Primary Purpose

Extrahepatic Bile Duct Cancer, Gallbladder Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
capecitabine
gemcitabine hydrochloride
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed gallbladder cancer or cholangiocarcinoma Locally advanced or metastatic disease that is unresectable Eligible subtypes: Adenocarcinoma, intestinal type Adenocarcinoma, not otherwise specified (NOS) Papillary carcinoma Clear cell adenocarcinoma Mucinous carcinoma Signet ring cell carcinoma Squamous cell carcinoma Adenosquamous carcinoma Small cell carcinoma Undifferentiated carcinoma Carcinoma, NOS OR Histologically confirmed adenocarcinoma of a metastatic site with clinical documentation* of gallbladder or bile duct involvement and no evidence of another primary NOTE: *If clinical documentation of gallbladder or bile duct involvement is not possible due to removal of the organ, a clinically and/or radiographically consistent picture plus pathologic findings from the metastatic site consistent with cholangiocarcinoma are allowed Measurable disease located outside prior radiotherapy port No carcinoid tumors or sarcomas PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) no greater than 2.5 times ULN (5 times ULN if liver metastasis is present) Renal: Creatinine clearance at least 30 mL/min Cardiovascular: No clinically significant cardiac disease that is not well controlled by medication No congestive heart failure No symptomatic coronary artery disease No cardiac arrhythmias No myocardial infarction within the past 12 months Gastrointestinal: Able to swallow and/or receive medications via gastrostomy feeding tube No intractable nausea or vomiting No malabsorption syndrome Other: No severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil No other malignancy within the past 5 years except: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Adequately treated stage I or II cancer currently in complete remission Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Prior neoadjuvant or adjuvant immunotherapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease No concurrent immunotherapy Chemotherapy: Prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease No other concurrent chemotherapy Endocrine therapy: Prior neoadjuvant or adjuvant hormonal therapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease No concurrent hormonal therapy Radiotherapy: See Disease Characteristics See Chemotherapy Recovered from prior radiotherapy Prior neoadjuvant or adjuvant radiotherapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease No prior radiotherapy to 25% or more of bone marrow No concurrent radiotherapy except for palliation of metastatic sites not considered target lesions Surgery: At least 2 weeks since prior surgery for this malignancy and recovered Other: No prior treatment for metastatic disease No other concurrent therapy for this cancer

Sites / Locations

  • Mobile Infirmary Medical Center
  • Providence Alaska Medical Center
  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Alta Bates Comprehensive Cancer Center
  • North Bay Cancer Center
  • Marin Cancer Institute at Marin General Hospital
  • Sutter Health Western Division Cancer Research Group
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • Memorial Hospital Cancer Center
  • West Florida Regional Medical Center
  • Hematology Oncology Associates of Eastern Idaho
  • Saint Anthony's Hospital at Saint Anthony's Health Center
  • Cancer Care Center at St. Francis Hospital
  • South Central Kansas Regional Medical Center
  • Cancer Center of Kansas - Chanute
  • Cancer Center of Kansas - Dodge City
  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  • Cancer Center of Kansas - Kingman
  • Southwest Medical Center
  • Cancer Center of Kansas - McPherson
  • Cancer Center of Kansas - Newton
  • Pratt Cancer Center of Kansas
  • Salina Regional Health Center
  • Cancer Center of Kansas - Salina
  • Cancer Center of Kansas - Wellington
  • Associates in Womens Health
  • Cancer Center of Kansas, P.A. - Wichita
  • CCOP - Wichita
  • Via Christi Cancer Center at Via Christi Regional Medical Center
  • Cancer Center of Kansas - Winfield
  • Markey Cancer Center at University of Kentucky Chandler Medical Center
  • Louisiana State University Health Sciences Center - Monroe
  • Tulane Cancer Center at Tulane University Hospital and Clinic
  • Cancer Treatment Center at Christus Schumpert St. Mary Place
  • Veterans Affairs Medical Center - Shreveport
  • Louisiana State University Health Sciences Center - Shreveport
  • Cancer Center at Thibodaux Regional Medical Center
  • Battle Creek Health System
  • Mecosta County General Hospital
  • Josephine Ford Cancer Center at Henry Ford Health System
  • CCOP - Grand Rapids
  • Lacks Cancer Center at Saint Mary's Mercy Medical Center
  • Spectrum Health Cancer Care - Butterworth Campus
  • Metropolitan Hospital
  • Spectrum Health Hospital - Blodgett Campus
  • Holland Community Hospital
  • Hackley Hospital
  • Northern Michigan Hospital
  • Munson Medical Center
  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
  • St. Francis Medical Center
  • CCOP - Kansas City
  • CCOP - St. Louis-Cape Girardeau
  • Center for Cancer Care and Research
  • David C. Pratt Cancer Center at St. John's Mercy
  • St. John's Regional Health Center
  • Hulston Cancer Center at Cox Medical Center South
  • CCOP - Montana Cancer Consortium
  • Great Falls Clinic
  • Sletten Regional Cancer Institute
  • Veterans Affairs Medical Center - Albuquerque
  • Adirondack Cancer Care
  • Orange Regional Medical Center - Horton Campus
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Mission Hospitals - Memorial Campus
  • Blumenthal Cancer Center at Carolinas Medical Center
  • Presbyterian Cancer Center at Presbyterian Hospital
  • Wayne Memorial Hospital, Incorporated
  • Cancer Center at Iredell Memorial Hospital
  • Forsyth Regional Cancer Center at Forsyth Medical Center
  • University Hospitals Ireland Cancer Center at Mercy Medical Center
  • Adena Regional Medical Center
  • Veterans Affairs Medical Center - Cincinnati
  • Charles M. Barrett Cancer Center at University Hospital
  • Cleveland Clinic Taussig Cancer Center
  • CCOP - Columbus
  • Riverside Methodist Hospital Cancer Care
  • Grandview Hospital
  • Good Samaritan Hospital
  • Miami Valley Hospital
  • Samaritan North Cancer Care Center
  • CCOP - Dayton
  • Grady Memorial Hospital
  • Community Oncology Group - Independence
  • Charles F. Kettering Memorial Hospital
  • Fairfield Medical Center
  • Strecker Cancer Center at Marietta Memorial Hospital
  • Middletown Regional Hospital
  • Licking Memorial Cancer Care Program at Licking Memorial Hospital
  • Community Hospital of Springfield and Clark County
  • UVMC Cancer Care Center at Upper Valley Medical Center
  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  • Cancer Institute at Oregon Health and Science University
  • Hollings Cancer Center at Medical University of South Carolina
  • McLeod Regional Medical Center
  • Bon Secours St. Francis Health System
  • CCOP - Greenville
  • Veterans Affairs Medical Center - Amarillo
  • CCOP - Scott and White Hospital
  • Huntsman Cancer Institute at University of Utah
  • Memorial Hospital of Martinsville and Henry County
  • St. Joseph Hospital Community Cancer Center
  • Harborview Medical Center
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  • Veterans Affairs Medical Center - Seattle
  • Fred Hutchinson Cancer Research Center
  • Group Health Central Hospital
  • University Cancer Center at University of Washington Medical Center
  • Central Washington Hospital
  • Wenatchee Valley Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capecitabine + Gemcitabine

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival
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
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
Only eligible patients who received treatment were evaluable for response and survival outcomes.
Median Survival Time for Participants With Relevant Biologic Markers
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.

Full Information

First Posted
April 9, 2002
Last Updated
August 14, 2017
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00033540
Brief Title
S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma
Official Title
A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients With Unresectable or Metastatic Gallbladder or Cholangiocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capecitabine + Gemcitabine
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
capecitabine
Other Intervention Name(s)
Xeloda (NSC-712807)
Intervention Description
650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Other Intervention Name(s)
Gemzar (NSC-613327)
Intervention Description
1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1,8, every 21 days
Primary Outcome Measure Information:
Title
Response
Description
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.
Time Frame
Patients assessed at least every six weeks while on protocol treatment
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Measured from time of registration to death, or last contact date
Time Frame
All patients will be followed until death or three years after registration, whichever is first.
Title
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Description
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.
Time Frame
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.
Title
Accrual of Patients With This Disease Site
Description
Only eligible patients who received treatment were evaluable for response and survival outcomes.
Time Frame
1-20 months
Title
Median Survival Time for Participants With Relevant Biologic Markers
Description
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.
Time Frame
All patients will be followed until death or three years after registration, whichever is first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed gallbladder cancer or cholangiocarcinoma Locally advanced or metastatic disease that is unresectable Eligible subtypes: Adenocarcinoma, intestinal type Adenocarcinoma, not otherwise specified (NOS) Papillary carcinoma Clear cell adenocarcinoma Mucinous carcinoma Signet ring cell carcinoma Squamous cell carcinoma Adenosquamous carcinoma Small cell carcinoma Undifferentiated carcinoma Carcinoma, NOS OR Histologically confirmed adenocarcinoma of a metastatic site with clinical documentation* of gallbladder or bile duct involvement and no evidence of another primary NOTE: *If clinical documentation of gallbladder or bile duct involvement is not possible due to removal of the organ, a clinically and/or radiographically consistent picture plus pathologic findings from the metastatic site consistent with cholangiocarcinoma are allowed Measurable disease located outside prior radiotherapy port No carcinoid tumors or sarcomas PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) no greater than 2.5 times ULN (5 times ULN if liver metastasis is present) Renal: Creatinine clearance at least 30 mL/min Cardiovascular: No clinically significant cardiac disease that is not well controlled by medication No congestive heart failure No symptomatic coronary artery disease No cardiac arrhythmias No myocardial infarction within the past 12 months Gastrointestinal: Able to swallow and/or receive medications via gastrostomy feeding tube No intractable nausea or vomiting No malabsorption syndrome Other: No severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil No other malignancy within the past 5 years except: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Adequately treated stage I or II cancer currently in complete remission Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Prior neoadjuvant or adjuvant immunotherapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease No concurrent immunotherapy Chemotherapy: Prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease No other concurrent chemotherapy Endocrine therapy: Prior neoadjuvant or adjuvant hormonal therapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease No concurrent hormonal therapy Radiotherapy: See Disease Characteristics See Chemotherapy Recovered from prior radiotherapy Prior neoadjuvant or adjuvant radiotherapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease No prior radiotherapy to 25% or more of bone marrow No concurrent radiotherapy except for palliation of metastatic sites not considered target lesions Surgery: At least 2 weeks since prior surgery for this malignancy and recovered Other: No prior treatment for metastatic disease No other concurrent therapy for this cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syma Iqbal, MD
Organizational Affiliation
University of Southern California
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Heinz-Josef Lenz, MD
Organizational Affiliation
University of Southern California
Official's Role
Study Chair
Facility Information:
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36652-2144
Country
United States
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99519-6604
Country
United States
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
North Bay Cancer Center
City
Fairfield
State/Province
California
ZIP/Postal Code
94533
Country
United States
Facility Name
Marin Cancer Institute at Marin General Hospital
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Sutter Health Western Division Cancer Research Group
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Memorial Hospital Cancer Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
West Florida Regional Medical Center
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514-6088
Country
United States
Facility Name
Hematology Oncology Associates of Eastern Idaho
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Saint Anthony's Hospital at Saint Anthony's Health Center
City
Alton
State/Province
Illinois
ZIP/Postal Code
62002
Country
United States
Facility Name
Cancer Care Center at St. Francis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
South Central Kansas Regional Medical Center
City
Arkansas City
State/Province
Kansas
ZIP/Postal Code
67005
Country
United States
Facility Name
Cancer Center of Kansas - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7353
Country
United States
Facility Name
Cancer Center of Kansas - Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Southwest Medical Center
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67901
Country
United States
Facility Name
Cancer Center of Kansas - McPherson
City
McPherson
State/Province
Kansas
ZIP/Postal Code
67460
Country
United States
Facility Name
Cancer Center of Kansas - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Pratt Cancer Center of Kansas
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Cancer Center of Kansas - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67402
Country
United States
Facility Name
Cancer Center of Kansas - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates in Womens Health
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3728
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
Via Christi Cancer Center at Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Markey Cancer Center at University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Monroe
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71210
Country
United States
Facility Name
Tulane Cancer Center at Tulane University Hospital and Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Cancer Treatment Center at Christus Schumpert St. Mary Place
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101-0000
Country
United States
Facility Name
Veterans Affairs Medical Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101-4295
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Cancer Center at Thibodaux Regional Medical Center
City
Thibodaux
State/Province
Louisiana
ZIP/Postal Code
70302-1118
Country
United States
Facility Name
Battle Creek Health System
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49016
Country
United States
Facility Name
Mecosta County General Hospital
City
Big Rapids
State/Province
Michigan
ZIP/Postal Code
49307
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Lacks Cancer Center at Saint Mary's Mercy Medical Center
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health Cancer Care - Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Metropolitan Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49506
Country
United States
Facility Name
Spectrum Health Hospital - Blodgett Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49506
Country
United States
Facility Name
Holland Community Hospital
City
Holland
State/Province
Michigan
ZIP/Postal Code
49423
Country
United States
Facility Name
Hackley Hospital
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49443-3302
Country
United States
Facility Name
Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63701
Country
United States
Facility Name
St. Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63701
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
CCOP - St. Louis-Cape Girardeau
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Center for Cancer Care and Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
David C. Pratt Cancer Center at St. John's Mercy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804-2263
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59403
Country
United States
Facility Name
Sletten Regional Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Veterans Affairs Medical Center - Albuquerque
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108-5138
Country
United States
Facility Name
Adirondack Cancer Care
City
Glens Falls
State/Province
New York
ZIP/Postal Code
12801
Country
United States
Facility Name
Orange Regional Medical Center - Horton Campus
City
Middletown
State/Province
New York
ZIP/Postal Code
10940-4199
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Mission Hospitals - Memorial Campus
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Presbyterian Cancer Center at Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233-3549
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27533
Country
United States
Facility Name
Cancer Center at Iredell Memorial Hospital
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28687-1828
Country
United States
Facility Name
Forsyth Regional Cancer Center at Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University Hospitals Ireland Cancer Center at Mercy Medical Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44708
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
45601
Country
United States
Facility Name
Veterans Affairs Medical Center - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220-2288
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0501
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-9001
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43206
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406-1891
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Samaritan North Cancer Care Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Community Oncology Group - Independence
City
Independence
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States
Facility Name
Charles F. Kettering Memorial Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
Strecker Cancer Center at Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750-1635
Country
United States
Facility Name
Middletown Regional Hospital
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45044-4898
Country
United States
Facility Name
Licking Memorial Cancer Care Program at Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055-2899
Country
United States
Facility Name
Community Hospital of Springfield and Clark County
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
UVMC Cancer Care Center at Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373-1300
Country
United States
Facility Name
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Cancer Institute at Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
McLeod Regional Medical Center
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Bon Secours St. Francis Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Veterans Affairs Medical Center - Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5550
Country
United States
Facility Name
Memorial Hospital of Martinsville and Henry County
City
Martinsville
State/Province
Virginia
ZIP/Postal Code
24115-4788
Country
United States
Facility Name
St. Joseph Hospital Community Cancer Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Veterans Affairs Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
Group Health Central Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
University Cancer Center at University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6043
Country
United States
Facility Name
Central Washington Hospital
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Wenatchee Valley Clinic
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18192902
Citation
Lurje G, Zhang W, Yang D, Groshen S, Hendifar AE, Husain H, Nagashima F, Chang HM, Fazzone W, Ladner RD, Pohl A, Ning Y, Iqbal S, El-Khoueiry A, Lenz HJ. Thymidylate synthase haplotype is associated with tumor recurrence in stage II and stage III colon cancer. Pharmacogenet Genomics. 2008 Feb;18(2):161-8. doi: 10.1097/FPC.0b013e3282f4aea6.
Results Reference
background
PubMed Identifier
21556747
Citation
Iqbal S, Rankin C, Lenz HJ, Gold PJ, Ahmad SA, El-Khoueiry AB, Messino MJ, Holcombe RF, Blanke CD. A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma: Southwest Oncology Group study S0202. Cancer Chemother Pharmacol. 2011 Dec;68(6):1595-602. doi: 10.1007/s00280-011-1657-1. Epub 2011 May 10.
Results Reference
result

Learn more about this trial

S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma

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