Clinical Trial: Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer

This study is currently recruiting patients.

Sponsored by: University of Texas
Information provided by: National Cancer Institute (NCI)


RATIONALE: 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.

PURPOSE: 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.

Condition Treatment or Intervention Phase
Breast Cancer
Cervical Cancer
Endometrial Cancer
Male Breast Cancer
ovarian epithelial cancer
ovarian germ cell tumor
 Drug: doxorubicin HCl liposome
 Drug: fluorouracil
 Procedure: chemotherapy
 Procedure: hyperthermia
Phase II

MedlinePlus related topics:  Breast Cancer;   Cancer;   Cancer Alternative Therapy;   Cervical Cancer;   Male Breast Cancer;   Ovarian Cancer;   Uterine Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official 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

Further Study Details: 


OUTLINE: This is a time-escalation study of systemic hyperthermia.

Patients receive fluorouracil IV continuously over 24 hours on days 1-5 and doxorubicin HCl liposome IV over 30 minutes on day 6. Beginning on day 7, patients receive heat applied for 6-24 hours (in 6-hour sequential treatments) using a mild hyperthermia-induction device. Treatment repeats every 4-5 weeks for a total of 4 courses. Patients who achieve less than a complete response but have no disease progression may receive additional courses of chemotherapy alone.

Cohorts of 5 patients receive escalating durations of hyperthermia until the recommended phase II duration is determined. The recommended phase II duration of hyperthermia is defined as the level preceding that at which 1 of 5 patients experiences measurable toxicity. (Phase I closed as of 9/28/01)

Patients are followed at 4 weeks and then every 6 months for 1 year.

PROJECTED ACCRUAL: A maximum of 34 patients will be accrued for this study within 48 months.


Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both



  • Histologically confirmed metastatic breast, ovarian, endometrial, or cervical carcinoma
  • Measurable and evaluable disease
  • No brain metastases
  • No hepatic involvement greater than 80%
  • No lung involvement greater than 30%
  • Hormone receptor status:
  • Not specified


  • 18 and over


  • Not specified

Menopausal status:

  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 12 weeks


  • Absolute granulocyte count greater than 1,500/mm^3
  • Platelet count greater than 90,000/mm^3
  • Normal bone marrow cellularity on bone marrow biopsy
  • Thrombin time less than 17 sec
  • Fibrinogen greater than 200 mg/dL
  • FSP less than 40
  • No coagulopathy


  • Bilirubin less than 2.0 mg/dL
  • SGPT less than 2 times normal
  • PT less than 14 sec
  • PTT less than 35 sec


  • BUN less than 25 mg/dL
  • Creatinine clearance at least 45 mL/min


  • Normal cardiovascular system
  • Resting ventricular ejection fraction greater than 40%
  • No prior myocardial infarction
  • No symptomatic coronary artery disease
  • No unstable blood pressure
  • No thromboembolic disease


  • No seizures or other CNS disorders
  • Negative computerized tomographic scan of brain


  • FEV_1 greater than 70% of predicted
  • Arterial pressure of oxygen greater than 60 mmHg on room air with appropriate pressure of carbon dioxide and pH values
  • No history of cardiopulmonary or respiratory disease


  • No other serious concurrent medical illness
  • No diabetes mellitus


  • Not specified


Endocrine therapy:

  • No adrenal corticosteroids


  • Not specified


  • Not specified


  • No concurrent cardiac glycosides, antianginal therapy, or antiarrhythmics
  • No concurrent vasodilators, anticoagulants, thrombolytic agents, or aspirin

Location and Contact Information

      University of Texas Health Science Center - Houston, Houston,  Texas,  77225,  United States; Recruiting
Joan M.C. Bull, MD  713-500-6820 

Study chairs or principal investigators

Joan M.C. Bull, MD,  Study Chair,  University of Texas   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065903; UTHSC-MS-96205; NCI-V97-1356; NCT00003135
Record last reviewed:  March 2002
Last Updated:  March 3, 2005
Record first received:  November 1, 1999 Identifier:  NCT00003135
Health Authority: United States: Federal Government processed this record on 2005-04-08

Cache Date: April 9, 2005