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A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy

This study is currently Recruiting

December 2008 By National Cancer Institute (NCI)

First Recieved on November 1, 1999

Last Updated on April 29, 2009

Sponsor: The University of Texas Health Science Center, Houston
Information provided by: National Cancer Institute (NCI)
Identifier: NCT00003135


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.

Study Type: Interventional
Study Design: Primary Purpose: Treatment


Ages Eligible for Study:18 Years
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No

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 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/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 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: - 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 Other: - No other serious concurrent medical illness - No diabetes mellitus 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


  • Investigator: Joan M.C. Bull, MD - Study Chair - The University of Texas Health Science Center, Houston


  • University of Texas Health Science Center at Houston

    Houston, Texas 77225 United States

Conditions related to this trial:

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