S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma
NCT ID: NCT00033540
Last Updated: 2017-09-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2003-09-30
2011-07-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Capecitabine + Gemcitabine
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
650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days
gemcitabine hydrochloride
1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1,8, every 21 days
Interventions
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capecitabine
650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days
gemcitabine hydrochloride
1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1,8, every 21 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Syma Iqbal, MD
Role: STUDY_CHAIR
University of Southern California
Heinz-Josef Lenz, MD
Role: STUDY_CHAIR
University of Southern California
Locations
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Mobile Infirmary Medical Center
Mobile, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
North Bay Cancer Center
Fairfield, California, United States
Marin Cancer Institute at Marin General Hospital
Greenbrae, California, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States
West Florida Regional Medical Center
Pensacola, Florida, United States
Hematology Oncology Associates of Eastern Idaho
Idaho Falls, Idaho, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States
Cancer Care Center at St. Francis Hospital
Indianapolis, Indiana, United States
South Central Kansas Regional Medical Center
Arkansas City, Kansas, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, 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
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Pratt Cancer Center of Kansas
Pratt, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates in Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Louisiana State University Health Sciences Center - Monroe
Monroe, Louisiana, United States
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Cancer Treatment Center at Christus Schumpert St. Mary Place
Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Cancer Center at Thibodaux Regional Medical Center
Thibodaux, Louisiana, United States
Battle Creek Health System
Battle Creek, Michigan, United States
Mecosta County General Hospital
Big Rapids, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, 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
Spectrum Health Hospital - Blodgett Campus
Grand Rapids, Michigan, United States
Holland Community Hospital
Holland, Michigan, United States
Hackley Hospital
Muskegon, Michigan, United States
Northern Michigan Hospital
Petoskey, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Cape Girardeau, Missouri, United States
St. Francis Medical Center
Cape Girardeau, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
Center for Cancer Care and Research
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Sletten Regional Cancer Institute
Great Falls, Montana, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States
Adirondack Cancer Care
Glens Falls, New York, United States
Orange Regional Medical Center - Horton Campus
Middletown, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Cancer Center at Iredell Memorial Hospital
Statesville, North Carolina, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States
University Hospitals Ireland Cancer Center at Mercy Medical Center
Canton, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Cancer Care Center
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Community Oncology Group - Independence
Independence, Ohio, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Middletown Regional Hospital
Middletown, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Bon Secours St. Francis Health System
Greenville, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Memorial Hospital of Martinsville and Henry County
Martinsville, Virginia, United States
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Group Health Central Hospital
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
Central Washington Hospital
Wenatchee, Washington, United States
Wenatchee Valley Clinic
Wenatchee, Washington, United States
Countries
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References
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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.
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.
Other Identifiers
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S0202
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000069299
Identifier Type: -
Identifier Source: org_study_id
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