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Home > "P" Clinical Trials Conditions > Pegylated Liposomal Doxorubicin compared to Capecitabine in treating Women 65 Years and Older with Metastatic Breast Cancer  Pegylated Liposomal Doxorubicin compared to Capecitabine in treating Women 65 Years and Older with Metastatic Breast Cancer
Pegylated Liposomal Doxorubicin compared to Capecitabine in treating Women 65 Years and Older with Metastatic Breast Cancer
For Condition: Metastatic breast cancer
Status: Recruiting
Sponsor(s): Tibotec Pharmaceutical ,
Synopsis: The purpose of this study is to compare the anti-cancer effects and the side effects of two chemotherapy medications, pegylated liposomal doxorubicin and capecitabine, in the treatment of metastatic breast cancer. Quality of life while taking chemotherapy will also be monitored to better understand how women 65 years of age and older feel day-to-day while taking either pegylated liposomal doxorubicin or capecitabine.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label
Minimum Age/Maximum Age: 65 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - Female 65 years of age with metastatic breast cancer - ECOG performance status 0-2 - Adequate bone marrow function: ANC 1500 cells /µl, platelet count 100,000/µl, hemoglobin 9.0 g/dL - Adequate renal function: Calculated creatinine clearance 30 mL/minute - Adequate liver function: bilirubin within institutional normal limits, ALT and AST 2X upper limit of normal - Baseline assessment of LVEF by MUGA scan or echocardiogram within six weeks of randomization indicates LVEF > 45% Exclusion Criteria: - Prior chemotherapy for metastatic disease - Treatment with capecitabine or pegylated liposomal doxorubicin in the adjuvant setting - Total cumulative anthracycline dose exceeding 300 mg/m2 for doxorubicin or 540 mg/m2 for epirubicin - Patients with anthracycline resistant disease. Anthracycline resistance is defined as development of locally recurrent or metastatic disease while on adjuvant anthracycline therapy, or relapse less than 18 months after completion of adjuvant anthracycline therapy - Patients with inflammatory breast cancer. - Patients who are taking concomitant medications for metastatic disease, including hormonal therapy, radiation therapy, or biologics (i.e., trastuzumab). - 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 - Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.
Total Enrollment:
Location and Contact Information:
Cancer Center of Colorado Springs *Recruiting*
Colorado Springs, Colorado, 80907
United States
Recruiting Kaye Whitt 719-444-4807
Western Washington Medical Group *Recruiting*
Everett, Washington, 98201
United States
Recruiting Linda Jacobson 425-258-9388
Vermont Center for Cancer Medicine *Recruiting*
Colchester, Vermont, 05446
United States
Recruiting Megan Bast 802-655-3400
University of Vermont-Fletcher Allen Health Care, Hematology-Oncology *Recruiting*
Burlington, Vermont, 05401
United States
Recruiting CeCe Sullivan 802-656-8990
Christus Schumpert Medical Center-Oncology Research *Recruiting*
Shreveport, Louisiana, 71101
United States
Recruiting Martha Lennard 318-681-6007
New Mexico Cancer Care Associates-Cancer Institute of New Mexico *Recruiting*
Sante Fe, New Mexico, 87505
United States
Recruiting Carmen Angel 505-955-7910
Additional Information:
Study ID Numbers: DO03-21-022;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082095
Other Metastatic Breast Cancer Studies:
1. Capecitabine (Xeloda) With Or Without GW572016 For Women With Refractory Advanced Or Metastatic Breast Cancer
2. Phase 2 randomized, placebo-controlled, double blind study of study drug in combination with Docetaxel versus Docetaxel alone for patients with Metastatic Breast Cancer.
3. Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer
4. Pegylated Liposomal Doxorubicin compared to Capecitabine in treating Women 65 Years and Older with Metastatic Breast Cancer
5. An Investigational Drug versus Capecitabine in Male or Female Patients with Advanced Breast Cancer
Related Studies:
Other Metastatic breast cancer Clinical Trials
Other Colorado Clinical Trials
Other Colorado Springs Clinical Trials
Pegylated Liposomal Doxorubicin compared to Capecitabine in treating Women 65 Years and Older with Metastatic Breast Cancer
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