- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00082095
To Compare Treatment With Doxorubicin or Capecitabine for Metastatic Breast Cancer in Women 60 Years and Older
October 8, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Randomized, Open-Label Trial Comparing Treatment With Either Pegylated Liposomal Doxorubicin or Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer in Women 60 Years and Older
The main purpose of this study is to compare treatment with either pegylated liposomal doxorubicin or capecitabine as first line chemotherapy for metastatic breast cancer in women 60 years and older.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), multicenter study comparing with pegylated liposomal doxorubicin (PLD) with capecitabine as first line chemotherapy of metastatic breast cancer in women 60 years and older.
The study consists of a screening Phase (up to 14 days prior to treatment), treatment phase (up to 1 year), and post-treatment follow-up phase.
The planned duration of treatment was 1 year in the absence of disease progression or unacceptable toxicity.
Approximately 300 patients will be enrolled and randomly assigned to receive 1 of 2 treatment groups (PLD or capecitabine).
Safety evaluations will consist of vital sign examination, physical examination, incidence and severity of adverse events, and laboratory tests findings and will be followed throughout the study.
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Fountain Valley, California, United States
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Oxnard, California, United States
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Soquel, California, United States
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Florida
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Boca Raton, Florida, United States
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New Port Richey, Florida, United States
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Plantation, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Illinois
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Springfield, Illinois, United States
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Kentucky
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Hazard, Kentucky, United States
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Louisiana
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Shreveport, Louisiana, United States
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Maine
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Scarborough, Maine, United States
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Maryland
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Baltimore, Maryland, United States
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Michigan
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Clinton Township, Michigan, United States
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Minnesota
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St Louis Park, Minnesota, United States
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New Hampshire
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Lebanon, New Hampshire, United States
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New Jersey
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Voorhees, New Jersey, United States
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New Mexico
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Albuquerque, New Mexico, United States
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New York
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Armonk, New York, United States
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New City, New York, United States
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Oregon
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Portland, Oregon, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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Texas
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Fort Worth, Texas, United States
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Fredericksburg, Texas, United States
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Vermont
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Burlington, Vermont, United States
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Colchester, Vermont, United States
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Washington
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Everett, Washington, United States
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Vancouver, Washington, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Clinically or pathologically proven metastatic breast cancer
- Eastern Cooperative Oncology Group performance status between 0-2
- Adequate bone marrow, renal and liver functions within normal limits
- Left ventricular ejection fractions more than 45% measured by multiple gated acquisition scan or echocardiogram within 6 weeks of randomization
Exclusion Criteria:
- Prior chemotherapy for metastatic disease (hormonal or chemotherapy in adjuvant setting and hormonal therapy in metastatic setting is allowed)
- Prior treatment with capecitabine or pegylated liposomal doxorubicin in the adjuvant setting (prior anthracyclines up to certain dose limit is allowed)
- Evidence of brain metastases unless previously treated and asymptomatic for 3 months or greater
- History of cardiac disease with New York Heart Association Class II or greater or clinical evidence of congestive heart failure
- Anthracycline resistant disease (locally recurrent or metastatic disease while on adjuvant anthracycline therapy or relapse less than 18 months after therapy completion)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Group 1 (doxorubicin)
Pegylated liposomal doxorubicin 40 mg/m2 administered intravenously on Day 1 of each cycle.
Cycle is repeated every 28 days, up to one year.
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Type=exact number, unit=mg/m2, number=40, form=infusion, route=intravenous.
Pegylated liposomal doxorubicin will be administered on Day 1 of each cycle.
Cycle will be repeated every 28 days, up to 1 year.
Other Names:
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Active Comparator: Group 2 (capecitabine )
Capecitabine administered orally at a dosage of 2000 mg/m2/day (1000 mg/m2 BID) for 14 consecutive days followed by a 7-day rest period.
Cycle is repeated every 21 days, up to one year.
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Type=exact number, unit=mg, number=500, form=tablet, route=oral.
Capecitabine will be administered at a dosage of 1000 mg/m2 twice daily for 14 consecutive days followed by a 7-day rest period.
Cycle is repeated every 21 days, up to one year.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to disease progression
Time Frame: Up to disease progression or death
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Time to disease progression is the duration in months from the date of randomization to the first documented evidence of disease progression or death caused by disease progression before the end of study.
Time to disease progression will be compared between patients treated with doxorubicin and capecitabine.
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Up to disease progression or death
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overall Response rate
Time Frame: Up to disease progression or death
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Overall response rate is measured as the number of patient with complete and partial responses.
It will be compared between patients treated with doxorubicin and capecitabine.
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Up to disease progression or death
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Overall survival
Time Frame: Up to 2 years after last patient is enrolled or death
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Overall survival is the duration from date of randomization to the date of death due to any cause during the study.
It will be compared between patients treated with doxorubicin and capecitabine.
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Up to 2 years after last patient is enrolled or death
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Number of patients with adverse events
Time Frame: Up to 1 month after intake of last dose of study medication
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Safety evaluated as "number of patients with adverse events" is compared between 2 treatment groups (doxorubicin and capecitabine).
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Up to 1 month after intake of last dose of study medication
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The European Organization for Research and Treatment of Cancer (EORTC) QLQ (Quality of Life Questionnaire) - C30
Time Frame: Day 1 and end of treatment
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The 30 item questionnaire to assess quality of life incorporates five functional scales: general physical symptoms, physical functioning, psychological distress, social functioning, and fatigue/malaise.
Most items are rated on a 4 point Likert scale ranging from 0 = "not at all" to 4 = "very much".
The effect of doxorubicin and capecitabine on the quality of life measured by the EORTC QLQ-C30 is assessed.
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Day 1 and end of treatment
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Subjective Significance Questionnaire (SSQ)
Time Frame: Day 1 and end of treatment
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The SSQ consists of 4 items in which patients rate the degree to which they experienced an improvement or deterioration in their physical condition, emotional state, ability to enjoy their social life, and overall quality of life since there last QOL assessment.Each of the four items are rated on a 7 point Likert scale ranging from 0 = "very much worse" to 7 = "very much better".
The effect of doxorubicin and capecitabine on the quality of life measured by the SSQ is assessed.
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Day 1 and end of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
April 29, 2004
First Submitted That Met QC Criteria
April 29, 2004
First Posted (Estimate)
April 30, 2004
Study Record Updates
Last Update Posted (Estimate)
October 9, 2014
Last Update Submitted That Met QC Criteria
October 8, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Capecitabine
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- CR004645
- DO03-21-022 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
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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