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 recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2001 by National Center for Research Resources (NCRR).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00006433
First received: November 3, 2000
Last updated: June 23, 2005
Last verified: November 2001

November 3, 2000
June 23, 2005
January 2000
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00006433 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided

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.

Not Provided
Interventional
Phase 2
Primary Purpose: Treatment
Breast Cancer
  • Drug: Doxil
  • Procedure: heat treatment
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
Not Provided
Not Provided

Inclusion Criteria:

  • Patients with recurrent or metastatic breast cancer
Female
18 Years to 90 Years
No
Contact: Janye Blivin, R.N., M.S.N. 1-919-660-2174
United States
 
NCT00006433
NCRR-M01RR00030-0156, M01RR00030
Not Provided
Not Provided
National Center for Research Resources (NCRR)
Not Provided
Principal Investigator: Leonard R. Prosnitz, M.D.
National Center for Research Resources (NCRR)
November 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP