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Gemcitabine and Capecitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Gallbladder Cancer or Cholangiocarcinoma
This study is ongoing, but not recruiting participants.
First Received: April 9, 2002   Last Updated: July 23, 2008   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  • SGOT or 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033540

  Hide Study Locations
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
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Investigator: Syma Iqbal, MD USC/Norris Comprehensive Cancer Center
Investigator: Heinz-Josef Lenz, MD USC/Norris Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Iqbal S, et al.: SWOG S0202: a phase II trial of gemcitabine and capecitabine in patients (pts) with unresectable or metastatic gallbladder cancer or cholangiocarcinoma. [Abstract] J Clin Oncol 24 (Suppl 18): A-4134, 2006.

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

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009