A Study to Assess Xeloda (Capecitabine) in Patients With Locally Advanced or Metastatic Breast Cancer - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00077857

Purpose

This 2 arm study will compare the efficacy and safety of label dose Xeloda to that of a lower dose of Xeloda plus Taxotere in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline.Patients will be randomized to receive either 1250mg/m2 or 825mg/m2 po bid on days 1-14 of each 3 week cycle, in combination with Taxotere 75mg/m2 iv on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Breast Cancer	Drug: capecitabine [Xeloda] Drug: Taxotere	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-label Study of the Effect of Different Dosing Regimens of Xeloda in Combination With Taxotere on Disease Progression in Patients With Locally Advanced and/or Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Capecitabine

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Time to disease progression or death [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response, time to response, duration of overall response, time to treatment failure, overall survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs, premature withdrawals, planned vs received dose. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	440
Study Start Date:	July 2003
Estimated Study Completion Date:	January 2010

Arms	Assigned Interventions
1: Experimental	Drug: capecitabine [Xeloda] 1250mg/m2 iv on days 1-14 of each 3 week cycle. Drug: Taxotere 75mg/m2 iv on day 1 of each 3 week cycle
2: Experimental	Drug: capecitabine [Xeloda] 825mg/m2 iv on days 1-14 of each 3 week cycle. Drug: Taxotere 75mg/m2 iv on day 1 of each 3 week cycle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

women >=18 years of age;
>=1 target lesion;
locally advanced or metastatic breast cancer;
demonstrated resistance to anthracycline;
>=2 regimens of chemotherapy for advanced/metastatic disease.

Exclusion Criteria:

previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;
previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077857

Hide Study Locations

Locations

United States, Alabama

Hoover, Alabama, United States, 35216

Birmingham, Alabama, United States, 35233
United States, Arizona

Tucson, Arizona, United States, 85715
United States, California

Berkeley, California, United States, 94704

Poway, California, United States, 92064
United States, Florida

Miami Shores, Florida, United States, 33179

Fort Lauderdale, Florida, United States, 33308

Boca Raton, Florida, United States, 33486

Port St Lucie, Florida, United States, 34952

Tamarac, Florida, United States, 33321-2956

Jacksonville, Florida, United States, 32207

Inverness, Florida, United States, 34452
United States, Illinois

Urbana, Illinois, United States, 61801

Skokie, Illinois, United States, 60076
United States, Indiana

Beech Grove, Indiana, United States, 46107
United States, Iowa

Des Moines, Iowa, United States, 50314
United States, Kansas

Overland Park, Kansas, United States, 66210
United States, Louisiana

Houma, Louisiana, United States, 70360
United States, Maryland

Frederick, Maryland, United States, 21701

Rockville, Maryland, United States, 20850-3348

Baltimore, Maryland, United States, 21236

Baltimore, Maryland, United States, 21202
United States, Massachusetts

Boston, Massachusetts, United States, 02118
United States, Michigan

Detroit, Michigan, United States, 48202-2689

Kalamazoo, Michigan, United States, 49007
United States, Missouri

St Joseph, Missouri, United States, 64507

Jefferson City, Missouri, United States, 65109
United States, New Jersey

Summit, New Jersey, United States, 07901

Paramus, New Jersey, United States, 07652
United States, New York

Williamsville, New York, United States, 14221
United States, Ohio

Mayfield Heights, Ohio, United States, 44124

Canton, Ohio, United States, 44718
United States, Pennsylvania

Kingston, Pennsylvania, United States, 18704

Allentown, Pennsylvania, United States, 18104
United States, South Carolina

Charleston, South Carolina, United States, 29406

Columbia, South Carolina, United States, 29203
United States, Tennessee

Knoxville, Tennessee, United States, 37920

Collierville, Tennessee, United States, 38017
United States, Texas

Austin, Texas, United States, 78705

Houston, Texas, United States, 77030
United States, Vermont

Colchester, Vermont, United States, 05446
United States, Virginia

Abingdon, Virginia, United States, 24211
United States, Washington

Walla Walla, Washington, United States, 99362
Bosnia and Herzegovina

Sarajevo, Bosnia and Herzegovina, 71000

Mostar, Bosnia and Herzegovina, 88000

Tuzla, Bosnia and Herzegovina, 75000
China

Shanghai, China, 200032

Hangzhou, China, 310009

Beijing, China, 100021

Beijing, China, 100853

Dalian, China, 116011

Dalian, China, 116027

Tianjin, China, 300060

Bengbu, China, 233004
Czech Republic

Praha, Czech Republic, 180 00

Praha, Czech Republic, 150 06

Pardubice, Czech Republic, 532 03

Tabor, Czech Republic, 390 03

Praha, Czech Republic, 140 59
India

Ahmedabad, India, 380 016

Hyderabad, India, 500 082

Bangalore, India, 560027

Ludhiana, India, 141 001

Kolkata, India, 700 053

Hyderabad, India, 500 034

Hyderabad, India, 500 033

Jaipur, India, 302013

New Delhi, India, 110 085

Vellore, India, 632 004

Manipal, India, 576 104

Trivandrum, India, 695 011

Mumbai, India, 400 012

Cochin, India, 682 026

Bangalore, India, 560 078
Poland

Wroclaw, Poland, 50-981

Poznan, Poland, 61-878
Russian Federation

St Petersburg, Russian Federation, 197022

Ryazan, Russian Federation, 390046

Ivanovo, Russian Federation, 153040

Yaroslavl, Russian Federation, 150054

St Petersburg, Russian Federation, 197758

Kazan, Russian Federation, 420029

Moscow, Russian Federation, 115478

Kazan, Russian Federation, 420111

Moscow, Russian Federation, 109033

Samara, Russian Federation, 443066

Chelyabinsk, Russian Federation, 454087

Omsk, Russian Federation, 644013
South Africa

Durban, South Africa, 4001

Bloemfontein, South Africa, 9301

Polokwane, South Africa, 0699
Thailand

Chiang Mai, Thailand, 50200

Bangkok, Thailand, 10400

Khon Kaen, Thailand, 40002

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Disclosures Group )
Study ID Numbers:	NO16853
Study First Received:	February 12, 2004
Last Updated:	November 17, 2009
ClinicalTrials.gov Identifier:	NCT00077857 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Breast Neoplasms

Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009