To Compare Treatment With Doxorubicin or Capecitabine for Metastatic Breast Cancer in Women 60 Years and Older

This study has been terminated.
(The study was terminated due to poor recruitment (after enrolling 62 of planned 300 patients in 20 months).)
Sponsor:
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00082095
First received: April 29, 2004
Last updated: August 9, 2012
Last verified: August 2012

April 29, 2004
August 9, 2012
April 2004
December 2005   (final data collection date for primary outcome measure)
Time to disease progression [ Time Frame: Up to disease progression or death ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00082095 on ClinicalTrials.gov Archive Site
  • Overall Response rate [ Time Frame: Up to disease progression or death ] [ Designated as safety issue: No ]
    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.
  • Overall survival [ Time Frame: Up to 2 years after last patient is enrolled or death ] [ Designated as safety issue: Yes ]
    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.
  • Number of patients with adverse events [ Time Frame: Up to 1 month after intake of last dose of study medication ] [ Designated as safety issue: Yes ]
    Safety evaluated as "number of patients with adverse events" is compared between 2 treatment groups (doxorubicin and capecitabine).
  • The European Organization for Research and Treatment of Cancer (EORTC) QLQ (Quality of Life Questionnaire) - C30 [ Time Frame: Day 1 and end of treatment ] [ Designated as safety issue: No ]
    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.
  • Subjective Significance Questionnaire (SSQ) [ Time Frame: Day 1 and end of treatment ] [ Designated as safety issue: No ]
    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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To Compare Treatment With Doxorubicin or Capecitabine for Metastatic Breast Cancer in Women 60 Years and Older
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: Pegylated liposomal doxorubicin
    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 Name: DOXIL
  • Drug: Capecitabine
    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 Name: Xeloda
  • 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.
    Intervention: Drug: Pegylated liposomal doxorubicin
  • 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.
    Intervention: Drug: Capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
62
December 2005
December 2005   (final data collection date for primary outcome measure)

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)
Female
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00082095
CR004645, DO03-21-022
No
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP