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Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer
This study has been completed.
First Received: August 5, 2002   Last Updated: July 23, 2008   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00042965
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Drug: capecitabine
Drug: gemcitabine hydrochloride
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of Capecitabine Plus Gemcitabine For Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


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

Study Start Date: October 2002
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042965

  Hide Study Locations
Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143-0128
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Illinois
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612-7323
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
United States, Maryland
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States, 65201
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New York
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
North Shore University Hospital
Manhasset, New York, United States, 11030
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Pennsylvania
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
United States, Vermont
Green Mountain Oncology Group
Bennington, Vermont, United States, 05201
Vermont Cancer Center
Burlington, Vermont, United States, 05401-3498
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States, 05009
United States, Virginia
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Walter M. Stadler, MD, FACP University of Chicago
  More Information

Additional Information:
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.
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 ID Numbers: CDR0000069488, CLB-90008
Study First Received: August 5, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00042965     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Kidney Diseases
Gemcitabine
Capecitabine
Neoplasms by Histologic Type
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Carcinoma, Renal Cell
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009