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
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Doxil
heat treatment
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: Patients with recurrent or metastatic breast cancer
Sites / Locations
- Radiation Oncology, Duke University Medical CenterRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006433
First Posted
November 3, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT00006433
Brief 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2001
Overall Recruitment Status
Unknown status
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Doxil
Intervention Type
Procedure
Intervention Name(s)
heat treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with recurrent or metastatic breast cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janye Blivin, R.N., M.S.N.
Phone
1-919-660-2174
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard R. Prosnitz, M.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiation Oncology, Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
21170
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janye Blivin, RN, MSN
Phone
919-660-2174
First Name & Middle Initial & Last Name & Degree
Leonard R. Prosnitz, MD
12. IPD Sharing Statement
Learn more about this trial
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
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