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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of Whole Body Hyperthermia Combined With Doxorubicin HCl Liposome and Fluorouracil in Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Other	UTHSC-MS-96205 NCI-V97-1356, NCT00003135

Trial Description

Purpose:

Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hyperthermia may kill more tumor cells.

This phase II trial is studying how well giving fluorouracil and liposomal doxorubicin together with systemic hyperthermia works in treating patients with metastatic breast, ovarian, endometrial, or cervical cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable and evaluable disease
• No brain metastases
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive a 24-hour continuous infusion of fluorouracil on days 1-5 followed by an infusion of liposomal doxorubicin on day 6. One day later, patients will receive up to four 6-hour hyperthermia treatments. Treatment may be repeated every 4-5 weeks for four courses. Some patients may receive further chemotherapy without hyperthermia. Patients will be evaluated at 4 weeks and every 6 months for 1 year.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

University of Texas Health Science Center at Houston

Joan Bull, MD, Protocol chair		Ph: 713-500-6820 Email: joan.m.bull@uth.tmc.edu

U.S.A.
Texas
	Houston
	University of Texas Health Science Center at Houston
		Joan Bull, MD	Ph:  713-500-6820
			Email: joan.m.bull@uth.tmc.edu

Registry Information
Official Title		A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined with Liposomal Doxorubicin/5-Fluorouracil in Patients with Advanced Malignancy
Trial Start Date		1997-11-04
Trial Completion Date		2009-09-01 (estimated)
Registered in ClinicalTrials.gov		NCT00003135
Date Submitted to PDQ		1997-11-04
Information Last Verified		2008-12-28