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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006433
Recruitment Status : Unknown
Verified November 2001 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
First Posted : November 6, 2000
Last Update Posted : June 24, 2005
Information provided by:
National Center for Research Resources (NCRR)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Doxil Procedure: heat treatment Phase 2

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : January 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with recurrent or metastatic breast cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006433

Contact: Janye Blivin, R.N., M.S.N. 1-919-660-2174

United States, North Carolina
Radiation Oncology, Duke University Medical Center Recruiting
Durham, North Carolina, United States, 21170
Contact: Janye Blivin, RN, MSN    919-660-2174      
Principal Investigator: Leonard R. Prosnitz, MD         
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Principal Investigator: Leonard R. Prosnitz, M.D. Identifier: NCT00006433     History of Changes
Other Study ID Numbers: NCRR-M01RR00030-0156
M01RR000030 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 2001

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents