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Phase I/II Trial of Doxil and Hyperthermia for Breast Cancer Patients With Chest Wall Recurrence or Stage IV Disease With Locally Advanced Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Primary Purpose: Treatment
Intervention
Name: Doxil
Type: Drug
Name: heat treatment
Type: Procedure
Overall Status
Recruiting
Summary
Purpose: The purpose of this protocol is to evaluate the combination of Doxil chemotherapy and heat treatment for recurrent breast cancer located on the chestwall following mastectomy. This protocol also includes patients with metastatic breast cancer who have not had mastectomy but have advanced tumor remaining within the breast. Doxil is the drug adriamycin (also called doxorubicin) encapsulated in liposomes, which coats the drug with a small amount of lipid (fat). This chemotherapy is in a newer form which can be better delivered to the tumor tissue without causing as much systemic toxicity. We are combining heat treatment with this drug in an effort to further increase the delivery of drug to the tumor, which may give an increased tumor response.
Methods: The patients will be treated with chemotherapy followed by heat treatment. This will be given for 6 cycles approximately every 4 weeks. For the first cycle patients will need to be hospitalized 3 days for measurement of blood levels of drug as well as some additional radiology studies which will help us to determine whether the drug is preferentially distributed within tumor.
Methods: The patients will be treated with chemotherapy followed by heat treatment. This will be given for 6 cycles approximately every 4 weeks. For the first cycle patients will need to be hospitalized 3 days for measurement of blood levels of drug as well as some additional radiology studies which will help us to determine whether the drug is preferentially distributed within tumor.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:
- Patients with recurrent or metastatic breast cancer
- Patients with recurrent or metastatic breast cancer
Location
Radiation Oncology, Duke University Medical Center
Durham, North Carolina, United States
Status: Recruiting
Contact: Janye Blivin, RN, MSN - 919-660-2174
Start Date
January 2000
Sponsors
National Center for Research Resources (NCRR)
Source
National Center for Research Resources (NCRR)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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