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

NCT00006433 | Unknown Phase 2

• 2 other identifiers: NCRR-M01RR00030-0156M01RR000030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Interventions

Doxil DRUG

heat treatment PROCEDURE

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with recurrent or metastatic breast cancer

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead

Study Sites (1)

Radiation Oncology, Duke University Medical Center

Durham, North Carolina, 21170, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicin; Diathermy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Leonard R. Prosnitz, M.D.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janye Blivin, R.N., M.S.N.

CONTACT

1-919-660-2174

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 2000
• First Posted: November 6, 2000
• Study Start: January 1, 2000
• Last Updated: June 24, 2005

Record last verified: 2001-11

Locations

US (1)