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Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer Clinical research trials and Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer medical trials happen in hundreds of localities 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 measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer. Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer  Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer
Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer
For Condition: recurrent renal cell cancer,stage 4 renal cell cancer
Status: No longer recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy 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 capecitabine with gemcitabine in treating patients who have metastatic kidney cancer.
Details: OBJECTIVES: - Determine the objective response rate in patients with metastatic renal cell carcinoma treated with gemcitabine and capecitabine. - Determine the duration of overall and progression-free survival of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients are followed every 3 months for 1 year and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 8-9 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed renal cell carcinoma - Clinically confirmed metastatic disease (histologic documentation of metastatic disease not required) - Sarcomatoid renal cell carcinomas allowed - No pure sarcomas - No collecting duct (duct of Bellini) tumors, oncocytomas, or transitional cell tumors - Measurable disease - At least 20 mm by conventional techniques OR - At least 10 mm by spiral CT scan - Nonmeasurable lesions include the following: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Lymphangitis cutis/pulmonis - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - Patients with known brain metastases are eligible if they have undergone prior surgical resection and/or cranial irradiation, they currently do not require steroids or anticonvulsants, and there is no progressive disease on CT scan or MRI at least 4 weeks after completion of radiotherapy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal Renal - Creatinine clearance at least 30 mL/min Cardiac - No clinically significant cardiac disease - No congestive heart failure - No symptomatic coronary artery disease - No cardiac arrhythmias not well controlled with medication - No myocardial infarction within the past 12 months Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 3 months after study - No prior severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil - No malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract that would preclude absorption of capecitabine PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 4 weeks since prior chemotherapy and recovered - No prior gemcitabine - No prior fluoropyrimidines (e.g., fluorouracil, floxuridine, capecitabine, or fluorouracil-uracil) - No other concurrent chemotherapy Endocrine therapy - See Disease Characteristics - At least 4 weeks since prior megestrol - No concurrent hormones (e.g., megestrol) except steroids for adrenal failure, hormones for nondisease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - Prior radiotherapy to any lesion that may produce disability (e.g., unstable femur) allowed - No concurrent palliative radiotherapy Surgery - See Disease Characteristics - At least 4 weeks since prior major surgery and recovered Other - Any number of prior regimens allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WalterStadler, Study Chair, University of Chicago Cancer Research Center
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
McGill University
Montreal, Quebec, H2W 1S6
Canada
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Weill Medical College of Cornell University
New York City, New York, 10021
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Missouri Baptist Cancer Center
St. Louis, Missouri, 63131
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Additional Information:
Study ID Numbers: CDR0000069488; CLB-90008
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042965
Other Stage 4 Renal Cell Cancer Studies:
1. Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer
2. AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
3. Vaccine Therapy in Treating Patients With Kidney Cancer
4. Magnetic-Resonance-Guided Radiofrequency Ablation in Treating Patients With Primary Kidney Cancer, Liver Metastases, or Other Solid Tumors
5. Erlotinib in Treating Patients With Locally Advanced or Metastatic Papillary Renal Cell Cancer
Related Studies:
Other stage 4 renal cell cancer Clinical Trials
Other Nevada Clinical Trials
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Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer
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