DOXIL vs. Xeloda as First Line Chemotherapy for Metastatic Breast Cancer in Women 60 Years and Older

This study has been terminated.

( The study was terminated due to poor accrual after enrolling 62 of planned 300 patients in 20 months. )

First Received on April 29, 2004. Last Updated on June 8, 2011 History of Changes

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:	Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00082095

Purpose

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 DOXILÂ® or XelodaÂ®.

Condition	Intervention	Phase
Breast Neoplasms Breast Cancer Cancer of Breast Cancer of the Breast	Drug: pegylated liposomal doxorubicin hydrochloride (DOXIL®) or capecitabine (Xeloda®)	Phase III

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 Hydrochloride (DOXIL) or Capecitabine (Xeloda) as First Line Chemotherapy for Metastatic Breast Cancer in Women 60 Years and Older

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Capecitabine

U.S. FDA Resources

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

Primary Outcome Measures:

Time to disease progression, measured in months, and defined as the duration from randomization to the first documented evidence of disease progression or death caused by disease progression before the end of study.

Secondary Outcome Measures:

Overall Response, overall survival rate, and Quality of Life outcomes measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core 30 Items) and SSQ (Subjective Significance Questionnaires).

Enrollment:	62
Study Start Date:	April 2004
Study Completion Date:	December 2005

Detailed Description:

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® will 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.

Eligibility

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

Criteria

Inclusion Criteria:

Patient must have clinically or pathologically proven metastatic breast cancer
Measurable or non-measurable disease
ECOG performance status 0-2
Adequate bone marrow (ANC >= 1500, Platelets >= 100,000, Hemoglobin >= 9 g), renal (CrCl >= 30 mL/min) and liver (bilirubin within normal limits and ALT and AST <= 2 times upper limit of normal) functions
LVEF > 45% measured by MUGA 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 Xeloda® or DOXIL® 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 NYHA 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 < 18 months after therapy completion).

Contacts and Locations

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

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:

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 This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00082095 History of Changes
Other Study ID Numbers:	CR004645
Study First Received:	April 29, 2004
Last Updated:	June 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Breast Cancer
Metastatic
DOXIL®, Xeloda®, Pegylated Liposomal Doxorubicin
Capecitabine

Chemotherapy
Women
Elderly

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Doxorubicin
Capecitabine
Fluorouracil
Antibiotics, Antineoplastic

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012