A Study of Capecitabine In Combination With Docetaxel vs Capecitabine Followed by Docetaxel As First-Line Treatment For Metastatic Breast Cancer
NCT ID: NCT00087620
Last Updated: 2017-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
INTERVENTIONAL
2004-09-30
2004-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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XELODA [capecitabine]
Eligibility Criteria
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Inclusion Criteria
* Be female and at least 18 years of age. Note: must be 19 years of age if the patient is a resident of the state of Alabama
* Be ambulatory (outpatient) and have a Karnofsky performance status of more than 70%
* Have confirmed breast cancer with locally advanced and/or metastases
* Have at least one site with defined tumor
* Have met one of the study definitions of primary or nonprimary resistance to an anthracycline-containing therapy
Exclusion Criteria
* Women of childbearing potential with either a positive or no pregnancy test
* Women of childbearing potential unless using a reliable and appropriate contraceptive method (Postmenopausal women must have not had their period for at least 12 months to be considered of non-childbearing potential)
* Prior treatment with chemotherapy in the advanced/metastatic setting
* HER 2/neu positive status without prior treatment with trastuzumab
* Prior treatment with IV bolus 5-FU, continuous 5-FU infusion, capecitabine or other oral fluoropyrimidines
* Prior treatment with a taxane if less than 12 months passed from the time of therapy completion to relapse
* Mitomycin C or nitrosoureas within 6 weeks preceding treatment start
* Organ allografts requiring immunosuppressive therapy
* Radiotherapy to the skeleton within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiotherapy
* Hormonal therapy within 10 days preceding study treatment start
* Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery
* Blood transfusions/growth factors to aid hematologic recovery within 2 weeks prior to study treatment start
* Participation in any investigational drug study within 4 weeks preceding treatment start
* Prior unanticipated severe reaction to fluoropyrimidine therapy
* Known hypersensitivity to 5-fluorouracil, taxanes or any of the components of capecitabine
* Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues
* Evidence of CNS metastases
* History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma
* Clinically significant (i.e. active) cardiac disease
* Abnormal laboratory values
* Severe renal impairment
* Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
* Lack of physical integrity of the upper GI tract
* Life expectancy of less than 3 months
* Unwilling/unable to comply with the protocol
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Locations
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Little Rock, Arkansas, United States
Deer Park, California, United States
Greenbrae, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Orange, California, United States
Aurora, Colorado, United States
Boca Raton, Florida, United States
Boynton Beach, Florida, United States
Brooksville, Florida, United States
Hollywood, Florida, United States
New Port Richey, Florida, United States
Augusta, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
Waterloo, Iowa, United States
Lenexa, Kansas, United States
Lafayette, Louisiana, United States
Scarborough, Maine, United States
Baltimore, Maryland, United States
Prince Frederick, Maryland, United States
Lansing, Michigan, United States
Minneapolis, Minnesota, United States
Reno, Nevada, United States
Rochester, New York, United States
Durham, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Oklahoma City, Oklahoma, United States
Florence, South Carolina, United States
Corpus Christi, Texas, United States
Richardson, Texas, United States
Milwaukee, Wisconsin, United States
Racine, Wisconsin, United States
Countries
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Other Identifiers
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ML17771
Identifier Type: -
Identifier Source: org_study_id
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