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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: October 8, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Pegylated liposomal doxorubicin
Drug: Capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 62
Study Start Date: April 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082095

  Show 27 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00082095     History of Changes
Other Study ID Numbers: CR004645, DO03-21-022
Study First Received: April 29, 2004
Last Updated: October 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Metastatic breast cancer
Breast Cancer
Pegylated Liposomal Doxorubicin
Capecitabine
DOXIL
Xeloda

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Doxorubicin
Fluorouracil
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014