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Trial Title:
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
NCT ID:
NCT00006433
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Primary purpose:
Treatment
Intervention:
Intervention type:
Drug
Intervention name:
Doxil
Intervention type:
Procedure
Intervention name:
heat treatment
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with recurrent or metastatic breast cancer
Gender:
Female
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Radiation Oncology, Duke University Medical Center
Address:
City:
Durham
Zip:
21170
Country:
United States
Status:
Recruiting
Contact:
Last name:
Janye Blivin, RN, MSN
Phone:
919-660-2174
Investigator:
Last name:
Leonard R. Prosnitz, MD
Email:
Principal Investigator
Start date:
January 2000
Lead sponsor:
Agency:
National Center for Research Resources (NCRR)
Agency class:
NIH
Source:
National Center for Research Resources (NCRR)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00006433
