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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

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
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Doxil
Procedure: heat treatment
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Study Start Date: January 2000
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with recurrent or metastatic breast cancer
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006433

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

Locations
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
Investigators
Principal Investigator: Leonard R. Prosnitz, M.D.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006433     History of Changes
Other Study ID Numbers: NCRR-M01RR00030-0156, M01RR00030
Study First Received: November 3, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014