- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00042965
Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer
A Phase II Study Of Capecitabine Plus Gemcitabine For Metastatic Renal Cell Carcinoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada, H2W 1S6
- McGill University
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California
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La Jolla, California, United States, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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San Francisco, California, United States, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, United States, 94143-0128
- UCSF Comprehensive Cancer Center
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Delaware
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Wilmington, Delaware, United States, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, United States, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, United States, 20007
- Lombardi Cancer Center
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Florida
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Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, United States, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, United States, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
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Indiana
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South Bend, Indiana, United States, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Bettendorf, Iowa, United States, 52722
- Hematology Oncology Associates of the Quad Cities
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center
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Maryland
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Baltimore, Maryland, United States, 21201
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Memorial Medical Center - University Campus
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, United States, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, United States, 63110
- Barnes-Jewish Hospital
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Saint Louis, Missouri, United States, 63131
- Missouri Baptist Cancer Center
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Nebraska
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Omaha, Nebraska, United States, 68198-7680
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, United States, 14215
- Veterans Affairs Medical Center - Buffalo
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Manhasset, New York, United States, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, United States, 11030
- North Shore University Hospital
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10029
- Mount Sinai Medical Center, NY
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New York, New York, United States, 10021
- Weill Medical College of Cornell University
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Syracuse, New York, United States, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, United States, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, United States, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, United States, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- Western Pennsylvania Hospital
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Lifespan: The Miriam Hospital
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Texas
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Dallas, Texas, United States, 75235-9154
- Simmons Cancer Center - Dallas
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Vermont
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Bennington, Vermont, United States, 05201
- Green Mountain Oncology Group
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Burlington, Vermont, United States, 05401-3498
- Vermont Cancer Center
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White River Junction, Vermont, United States, 05009
- Veterans Affairs Medical Center - White River Junction
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Virginia
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Richmond, Virginia, United States, 23298-0037
- MBCCOP - Massey Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gemcitabine + capecitabine
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate
Time Frame: Up to 2 years
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Up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: Up to 2 years
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Up to 2 years
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Progression-free survival
Time Frame: Up to 2 years
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Up to 2 years
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Stadler WM, Halabi S, Rini B, Ernstoff MS, Davila E, Picus J, Barrier R, Small EJ; Cancer and Leukemia Group B. A phase II study of gemcitabine and capecitabine in metastatic renal cancer: a report of Cancer and Leukemia Group B protocol 90008. Cancer. 2006 Sep 15;107(6):1273-9. doi: 10.1002/cncr.22117.
- Stadler WM, Halabi S, Ernstoff MS, et al.: A phase II study of gemcitabine (G) and capecitabine (C) in patients with metastatic renal cell cancer (mRCC): a report of Cancer and Leukemia Group B #90008. [Abstract] J Clin Oncol 22 (Suppl 14): A-4515, 385s, 2004.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Capecitabine
Other Study ID Numbers
- CALGB-90008
- U10CA031946 (U.S. NIH Grant/Contract)
- CDR0000069488 (Registry Identifier: NCI Physician Data Query)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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