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Gemcitabine and Capecitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Gallbladder Cancer or Cholangiocarcinoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Gemcitabine and Capecitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Gallbladder Cancer or Cholangiocarcinoma conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Gemcitabine and Capecitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Gallbladder Cancer or Cholangiocarcinoma Clinical research trials and Gemcitabine and Capecitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Gallbladder Cancer or Cholangiocarcinoma health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Gemcitabine and Capecitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Gallbladder Cancer or Cholangiocarcinoma. Gemcitabine and Capecitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Gallbladder Cancer or Cholangiocarcinoma Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Gemcitabine and Capecitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Gallbladder Cancer or Cholangiocarcinoma clinical trial. Participants oftentimes recieve the most expert healthcare available for their Gemcitabine and Capecitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Gallbladder Cancer or Cholangiocarcinoma condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gemcitabine and Capecitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Gallbladder Cancer or Cholangiocarcinoma Gemcitabine and Capecitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Gallbladder Cancer or Cholangiocarcinoma
Gemcitabine and Capecitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Gallbladder Cancer or Cholangiocarcinoma
For Condition: extrahepatic bile duct cancer,Gallbladder Cancer
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: 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 metastaticgallbladder cancer or cholangiocarcinoma.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SymaIqbal, Study Chair, University of Southern California
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
CCOP - St. Louis-Cape Girardeau *Recruiting*
St. Louis, Missouri, 63141
United States
Recruiting Patrick Henry 314-569-6573
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting John Barstis 310-825-5268
Veterans Affairs Medical Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130
United States
Recruiting Glenn Mills 318-221-8411
University of Tennessee Cancer Institute *Recruiting*
Memphis, Tennessee, 38103
United States
Recruiting Mohammad Jahanzeb 901-722-0532
Veterans Affairs Medical Center - Houston *Recruiting*
Houston, Texas, 77030
United States
Recruiting Gauri Varadhachary 713-791-1414 ext. 5340
Veterans Affairs Medical Center - Albuquerque *Recruiting*
Albuquerque, New Mexico, 87108-5138
United States
Recruiting Douglas Clark 505-243-4039
Veterans Affairs Medical Center - Kansas City *Recruiting*
Kansas City, Missouri, 64128
United States
Recruiting Sarah Taylor 816-861-4700 ext. 491
Veterans Affairs Medical Center - Dayton *Recruiting*
Dayton, Ohio, 45428-1002
United States
Recruiting Howard Gross 937-268-6511
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) *Recruiting*
Phoenix, Arizona, 85012
United States
Recruiting Thomas Kummet 602-277-5551
Veterans Affairs Medical Center - Albany *Recruiting*
Albany, New York, 12208
United States
Recruiting James Holland 518-462-3311 ext. 2328
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
Veterans Affairs Medical Center - Jackson *Recruiting*
Jackson, Mississippi, 39216
United States
Recruiting James Thigpen 601-362-4471
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Anthony Elias 720-848-1622
Veterans Affairs Medical Center - New Orleans *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Alan Miller 504-589-5250
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John Roberts 804-828-0450
CCOP - Northwest *Recruiting*
Tacoma, Washington, 98405-0986
United States
Recruiting Lauren Colman 253-403-1461
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Heinz-Josef Lenz 323-865-3955
CCOP - Bay Area Tumor Institute *Recruiting*
Oakland, California, 94609-3305
United States
Recruiting Joseph Szumowski 510-465-8570
Veterans Affairs Medical Center - Detroit *Recruiting*
Detroit, Michigan, 48201-1932
United States
Recruiting Lawrence Flaherty 313-576-1000
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536-0084
United States
Recruiting Michael Doukas 859-257-4500
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange, California, 92868
United States
Recruiting Randall Holcombe 714-456-5153
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
CCOP - Beaumont *Recruiting*
Royal Oak, Michigan, 48073-6769
United States
Recruiting David Decker 248-551-7695
Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Carolyn Reed 843-792-3362
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
Veterans Affairs Medical Center - Salt Lake City *Recruiting*
Salt Lake City, Utah, 84148
United States
Recruiting Wolfram Samlowski 801-582-1565
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112-5550
United States
Recruiting Wolfram Samlowski 801-585-0255
Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita, Kansas, 67218
United States
Recruiting Shaker Dakhil 316-685-2221
Danville Radiation Therapy Center *Recruiting*
Memphis, Tennessee, 38104
United States
Recruiting Mohammad Jahanzeb 901-523-8990
MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cheryl Willman 505-272-5837
Veterans Affairs Medical Center - Oklahoma City *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-270-0501
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Robert Chapman 313-916-1850
Veterans Affairs Medical Center - San Antonio (Murphy) *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Geoffrey Weiss 210-617-5120
Veterans Affairs Medical Center - Little Rock (McClellan) *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Bart Barlogie 501-526-2873
Veterans Affairs Medical Center - Cincinnati *Recruiting*
Cincinnati, Ohio, 45220-2288
United States
Recruiting Abdul-Rahman Jazieh 513-861-3100 ext. 6537
Harrington Cancer Center *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting James Clarkson 806-359-4673
Madigan Army Medical Center *Recruiting*
Tacoma, Washington, 98431-5000
United States
Recruiting Patrick Williams 253-968-2505
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Daniel Petrylak 212-305-1731
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
Veterans Affairs Medical Center - Temple *Recruiting*
Temple, Texas, 76504
United States
Recruiting Phalguni Mukhopadhyay 254-778-4811 ext. 4809
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0912
United States
Recruiting Laurence Baker 734-936-3983
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting James Thigpen 601-984-5590
Veterans Affairs Medical Center - Charleston *Recruiting*
Charleston, South Carolina, 29401-5799
United States
Recruiting Andrew Turrisi 843-792-273
Veterans Affairs Outpatient Clinic - Martinez *Recruiting*
Martinez, California, 94553
United States
Recruiting David Gandara 925-372-2064
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
Tulane University School of Medicine *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Alan Miller 504-587-7566
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-0269
United States
Recruiting Kim Margolin 626-359-8111
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Kathleen Yost 616-391-1230
Veterans Affairs Medical Center - Seattle *Recruiting*
Seattle, Washington, 98108
United States
Recruiting William Schubach 206-764-2265
Veterans Affairs Medical Center - Portland *Recruiting*
Portland, Oregon, 97207
United States
Recruiting Craig Nichols 503-220-8262
Providence Cancer Institute at Providence Hospital *Recruiting*
Southfield, Michigan, 48075
United States
Recruiting Anibal Drelichman 313-552-0620
Veterans Affairs Medical Center - Amarillo *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting William Robinson 806-355-9703
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Laura Hutchins 501-686-8511
Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Thomas Lad 312-996-2046
St. Louis University Hospital Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Paul Petruska 314-577-8854
Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130-3932
United States
Recruiting Glenn Mills 318-675-7639
David Grant Medical Center *Recruiting*
Travis Air Force Base, California, 94535
United States
Recruiting David Gandara 707-423-7300
Veterans Affairs Medical Center - Ann Arbor *Recruiting*
Ann Arbor, Michigan, 48105
United States
Recruiting Laurence Baker 734-769-7100
CCOP - Atlanta Regional *Recruiting*
Atlanta, Georgia, 30342-1701
United States
Recruiting Thomas Seay 404-851-2340
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Lawrence Flaherty 313-745-9155
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0565
United States
Recruiting Robert Whitehead 409-772-1164
Veterans Affairs Medical Center - Lexington *Recruiting*
Lexington, Kentucky, 40502-2236
United States
Recruiting Michael Doukas 859-281-4956
CCOP - Montana Cancer Consortium *Recruiting*
Billings, Montana, 59101
United States
Recruiting Patrick Cobb 406-259-2245
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-241-6251
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
CCOP - Virginia Mason Research Center *Recruiting*
Seattle, Washington, 98101
United States
Recruiting Andrew Jacobs 206-341-0446
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting David Gandara 916-734-3772
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-544-1013
Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160-7353
United States
Recruiting Sarah Taylor 913-588-6029
Brooke Army Medical Center *Recruiting*
Fort Sam Houston, Texas, 78234-6200
United States
Recruiting Mitchell Garrison 210-916-0504
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78229-3900
United States
Recruiting Geoffrey Weiss 210-617-5120
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97201-3098
United States
Recruiting Craig Nichols 503-494-6346
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) *Recruiting*
Hines, Illinois, 60141
United States
Recruiting Nirmala Bhoopalam 708-202-2782
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Saul Rivkin 206-386-2929
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153-5500
United States
Recruiting Patrick Stiff 708-327-3148
Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi, Mississippi, 39531-2410
United States
Recruiting Robert Veith 504-568-5151
Cancer Research Center at Boston Medical Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Douglas Faller 617-638-8000
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94143-0128
United States
Recruiting Peter Carroll 415-353-7171
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Cancer Research Center of Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati, Ohio, 45267-0501
United States
Recruiting Abdul-Rahman Jazieh 513-584-3830
Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tucson, Arizona, 85724
United States
Recruiting Thomas Miller 520-626-2667
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
Veterans Affairs Medical Center - Tucson *Recruiting*
Tucson, Arizona, 85723
United States
Recruiting Thomas Miller 520-792-1450 ext. 16631
CCOP - Santa Rosa Memorial Hospital *Recruiting*
Santa Rosa, California, 95403
United States
Recruiting Ian Anderson 707-521-3859
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195-9001
United States
Recruiting George Budd 216-444-6480
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4095
United States
Recruiting Scott Lippman 713-745-3672
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Richard Fisher 585-275-0842
Additional Information:
Study ID Numbers: CDR0000069299; SWOG-S0202
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033540
Other Extrahepatic Bile Duct Cancer Studies:
1. BMS-247550 in Treating Patients With Liver or Gallbladder Cancer
2. Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer
3. Gemcitabine and Capecitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Gallbladder Cancer or Cholangiocarcinoma
4. Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas
Related Studies:
Other extrahepatic bile duct cancer Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials
Gemcitabine and Capecitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Gallbladder Cancer or Cholangiocarcinoma
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