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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)

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Cervical Cancer Endometrial Cancer Ovarian Cancer Drug: fluorouracil Drug: pegylated liposomal doxorubicin hydrochloride Procedure: hyperthermia treatment Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Primary Purpose: Treatment
Official Title: A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy
Study Start Date : November 1997
Estimated Primary Completion Date : September 2009

Primary Outcome Measures :
  1. Tumor response
  2. Toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003135

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United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77225
Contact: Joan M.C. Bull, MD    713-500-6820   
Sponsors and Collaborators
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
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Responsible Party: Joan M.C. Bull, University of Texas Health Science Center at Houston Identifier: NCT00003135    
Other Study ID Numbers: CDR0000065903
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 30, 2009
Last Verified: December 2008
Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
recurrent cervical cancer
stage IVB cervical cancer
stage IVA cervical cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
stage IV endometrial carcinoma
recurrent endometrial carcinoma
stage IV ovarian germ cell tumor
recurrent ovarian germ cell tumor
male breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Body Temperature Changes
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs