Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Whole Body Hyperthermia Combined With Chemotherapy in Treating 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

Objectives

1. 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.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Prior chemotherapy allowed

Endocrine therapy:

• No adrenal corticosteroids

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

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

Patient Characteristics:

Age:

• 18 and over

Sex:

• Not specified

Menopausal status:

• Not specified

Performance status:

• Zubrod 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute granulocyte count greater than 1,500/mm³
• Platelet count greater than 90,000/mm³
• 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

Hepatic:

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

Renal:

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

Cardiovascular:

• 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

Neurologic:

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

Pulmonary:

• FEV₁ 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

Other:

• No other serious concurrent medical illness
• No diabetes mellitus

Expected Enrollment

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

Outcomes

Tumor response
Toxicity

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.

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

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