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Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00082095 |
The purpose of this study is to compare the time to disease progression in women 60 years of age or older with metastatic breast cancer who are treated with DOXIL® or Xeloda®.
Condition | Intervention | Phase |
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Breast Neoplasms Cancer of Breast Breast Cancer Cancer of the Breast |
Drug: pegylated liposomal doxorubicin hydrochloride (DOXIL®) or capecitabine (Xeloda®) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label Trial Comparing Treatment With Either Pegylated Liposomal Doxorubicin Hydrochloride (DOXIL®) or Capecitabine (Xeloda®) as First Line Chemotherapy for Metastatic Breast Cancer in Women 60 Years and Older |
Estimated Enrollment: | 288 |
Study Start Date: | April 2004 |
Study Completion Date: | December 2005 |
This is an open-label, randomized, multicenter study comparing DOXIL® with Xeloda® as first line chemotherapy of metastatic breast cancer in women 60 years and older. Overall response rates and survival rates will be compared between the two treatment groups. Safety and quality of life assessments will also be compared between the two treatment groups. The study hypothesis is that the study drug will yield comparable efficacy (time to disease progression) with an improved tolerability profile.
DOXIL® willl be administered intravenously at a dose of 40 mg/m2 every 28 days for up to one year. Xeloda® will be administered orally at a dose of 1000 mg/m2 BID for 14 consecutive days followed by a 7-day rest period; This cycle is repeated every 21 days for up to one year.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR004645 |
Study First Received: | April 29, 2004 |
Last Updated: | April 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00082095 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metastatic Women Capecitabine Breast Cancer |
Chemotherapy Elderly DOXIL®, Xeloda®, Pegylated Liposomal Doxorubicin |
Antimetabolites Anti-Bacterial Agents Capecitabine Skin Diseases |
Breast Neoplasms Doxorubicin Breast Diseases |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Breast Neoplasms |
Antibiotics, Antineoplastic Doxorubicin Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Breast Diseases |