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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003135
Recruitment Status : Unknown
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : January 27, 2003
Last Update Posted : April 30, 2009
Information provided by:
National Cancer Institute (NCI)

November 1, 1999
January 27, 2003
April 30, 2009
November 1997
September 2009   (Final data collection date for primary outcome measure)
  • Tumor response
  • Toxicity
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Complete list of historical versions of study NCT00003135 on Archive Site
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Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy

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.


  • Evaluate tumor response and toxicity induced by fluorouracil and doxorubicin HCl liposome combined with mild systemic hyperthermia in patients with metastatic breast, ovarian, endometrial, or cervical cancer.

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.

Phase 2
Primary Purpose: Treatment
  • Breast Cancer
  • Cervical Cancer
  • Endometrial Cancer
  • Ovarian Cancer
  • Drug: fluorouracil
  • Drug: pegylated liposomal doxorubicin hydrochloride
  • Procedure: hyperthermia treatment
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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September 2009   (Final data collection date for primary outcome measure)


  • 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


Biologic therapy:

  • Not specified


  • Prior chemotherapy allowed

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Joan M.C. Bull, University of Texas Health Science Center at Houston
The University of Texas Health Science Center, Houston
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Study Chair: Joan M.C. Bull, MD The University of Texas Health Science Center, Houston
National Cancer Institute (NCI)
December 2008

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